510(k) Report

510(k) · Cleared

Cleared

Pta, PTV, Atrioseptostomy, Angiographic, Sizing Catheters

K040830510(k) SpecialCleared Jun 18, 200479-day reviewClass II21 CFR 870.1200

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

NuMED, Inc. · DQO Catheter, Intravascular, Diagnostic

Cleared on Jun 18, 2004 as substantially equivalent to K003902 (NuMED, Inc., 2001) and 18 other predicates after a 79-day review. Its family tree reaches back 2 generations to 1993. 1 later device descends from it.

Decided
Jun 18, 2004
Review
79 days
Class
Class II
Product code
DQO
Recalls
None
Predicates
19

Its longest line of descent runs back 2 generations to K931009 (1993). 19 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 2 other ancestors2002: 3 other ancestors2001: 5 other ancestors2000: 5 other ancestors1996: 2 other ancestors2016: 1 descendant clearedK931009 · Tyshak Peripheral Balloon Dilation Catheter · NuMED, Inc. · 1993 · recalledK991977 · Tyshak, Model 102 and Z-Med, Model 302 · NuMED, Inc. · 20001990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 17 other ancestors 1 generation forward: 1 descendant K991977 · Tyshak, Model 102 and Z-Med, Model 302 · NuMED, Inc. · 2000K931009 · Tyshak Peripheral Balloon Dilation Catheter · NuMED, Inc. · 1993 · recalled0
  1. Root · 2 generations backK931009 Tyshak Peripheral Balloon Dilation CatheterNuMED, Inc. · 1993 · Recalled
  2. 1 generation backK991977 Tyshak, Model 102 and Z-Med, Model 302NuMED, Inc. · 2000
  3. This deviceK040830 Pta, PTV, Atrioseptostomy, Angiographic, Sizing CathetersNuMED, Inc. · 2004
  4. Descendant · cites it directly · 0 of its ownK153069 Edwards Balloon CatheterEdwards Lifesciences · 2016

Most influential descendants

Showing 1 of 1 · See all
  • K153069Edwards Balloon CatheterEdwards Lifesciences · 2016 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K931009Tyshak Peripheral Balloon Dilation CatheterNuMED, Inc.19931
−1K991977Tyshak, Model 102 and Z-Med, Model 302NuMED, Inc.2000—
0 (this device)K040830Pta, PTV, Atrioseptostomy, Angiographic, Sizing CathetersNuMED, Inc.2004—
+1K153069Edwards Balloon CatheterEdwards Lifesciences2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199620
200050
200150
200230
200320

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201610
FIG. 1 — Lineage of K040830, 1993–2016Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DQO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new DQO device

  1. #1 K254278 Arterial Pressure Monitoring Set/Trayscore 14.4 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (19)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K003902Multitrack Angiographic Catheter
Summary page 1
…n Information: The current shelf life validation is for three years. Through the new validation and testing, NuMED would like to extend the shelf life to 5 years. K003902 - Multi-Track Angiographic Catheter K003972 - Ghost II PTA Catheter K003643 - Z-MED Catheter K003276 - Tyshak M…
NuMED, Inc.2001—
*K003972Numed Ghost II Pta Catheters
Summary page 1
…s for three years. Through the new validation and testing, NuMED would like to extend the shelf life to 5 years. K003902 - Multi-Track Angiographic Catheter K003972 - Ghost II PTA Catheter K003643 - Z-MED Catheter K003276 - Tyshak Mini Pediatric Catheter K003114 - Tyshak and…
NuMED, Inc.2001—
*K003643Numed Z-Med PTV Catherers
Summary page 1
…idation and testing, NuMED would like to extend the shelf life to 5 years. K003902 - Multi-Track Angiographic Catheter K003972 - Ghost II PTA Catheter K003643 - Z-MED Catheter K003276 - Tyshak Mini Pediatric Catheter K003114 - Tyshak and Z-MED Catheters K003052 - Tyshak…
NuMED, Inc.2000—
*K003276Tyshak Mini Pediatric PTV Catheter, Model 107
Summary page 1
…d like to extend the shelf life to 5 years. K003902 - Multi-Track Angiographic Catheter K003972 - Ghost II PTA Catheter K003643 - Z-MED Catheter K003276 - Tyshak Mini Pediatric Catheter K003114 - Tyshak and Z-MED Catheters K003052 - Tyshak lI and Z-MED II Catheters…
NuMED, Inc.2000—
*K003114Numed Tyshak and Z-Med PTV Catheters
Summary page 1
…K003902 - Multi-Track Angiographic Catheter K003972 - Ghost II PTA Catheter K003643 - Z-MED Catheter K003276 - Tyshak Mini Pediatric Catheter K003114 - Tyshak and Z-MED Catheters K003052 - Tyshak lI and Z-MED II Catheters K991977 - Tyshak and Z-MED PTV Catheters…
NuMED, Inc.2000—
*K003052Numed Tyshak II and Z-Med II PTV Catheters
Summary page 1
…eter K003972 - Ghost II PTA Catheter K003643 - Z-MED Catheter K003276 - Tyshak Mini Pediatric Catheter K003114 - Tyshak and Z-MED Catheters K003052 - Tyshak lI and Z-MED II Catheters K991977 - Tyshak and Z-MED PTV Catheters K001804 - Z-5 Atrioseptostomy Catheters…
NuMED, Inc.2000—
*K991977Tyshak, Model 102 and Z-Med, Model 302
Summary page 1
…K003643 - Z-MED Catheter K003276 - Tyshak Mini Pediatric Catheter K003114 - Tyshak and Z-MED Catheters K003052 - Tyshak lI and Z-MED II Catheters K991977 - Tyshak and Z-MED PTV Catheters K001804 - Z-5 Atrioseptostomy Catheters K960070 - Z-5 Atrioseptostomy Catheters…
NuMED, Inc.2000—
*K001804Numed Z-5 Atrioseptostomy Catheter
Summary page 1
…Mini Pediatric Catheter K003114 - Tyshak and Z-MED Catheters K003052 - Tyshak lI and Z-MED II Catheters K991977 - Tyshak and Z-MED PTV Catheters K001804 - Z-5 Atrioseptostomy Catheters K960070 - Z-5 Atrioseptostomy Catheters K931009 - Tyshak, Z-MLED, and Ghost PTA Cathe…
NuMED, Inc.2000—
*K960070Numed Atrioseptostomy Catheter
Summary page 1
…k and Z-MED Catheters K003052 - Tyshak lI and Z-MED II Catheters K991977 - Tyshak and Z-MED PTV Catheters K001804 - Z-5 Atrioseptostomy Catheters K960070 - Z-5 Atrioseptostomy Catheters K931009 - Tyshak, Z-MLED, and Ghost PTA Catheters K010880 - High Pressure Catheter (M…
NuMED, Inc.1996—
*K931009Tyshak Peripheral Balloon Dilation Catheter
Summary page 1
…I and Z-MED II Catheters K991977 - Tyshak and Z-MED PTV Catheters K001804 - Z-5 Atrioseptostomy Catheters K960070 - Z-5 Atrioseptostomy Catheters K931009 - Tyshak, Z-MLED, and Ghost PTA Catheters K010880 - High Pressure Catheter (Marauder) K952984 - Multi-Track Angiograp…
NuMED, Inc.19931
*K010880Numed High Pressure Pta Catheters
Summary page 1
…D PTV Catheters K001804 - Z-5 Atrioseptostomy Catheters K960070 - Z-5 Atrioseptostomy Catheters K931009 - Tyshak, Z-MLED, and Ghost PTA Catheters K010880 - High Pressure Catheter (Marauder) K952984 - Multi-Track Angiographic Catheter K030589 - Tyshak II and Z-MED II Cath…
NuMED, Inc.2001—
*K952984Map Multitrack Angiographic Catheter (4F)
Summary page 1
…y Catheters K960070 - Z-5 Atrioseptostomy Catheters K931009 - Tyshak, Z-MLED, and Ghost PTA Catheters K010880 - High Pressure Catheter (Marauder) K952984 - Multi-Track Angiographic Catheter K030589 - Tyshak II and Z-MED II Catheters K032591 - Tyshak Mini Pediatric Cathet…
Map Medical Equipment, Inc.19962
*K030589Modification to Numed Tyshak II and Z-Med II PTV Catheters
Summary page 1
…theters K931009 - Tyshak, Z-MLED, and Ghost PTA Catheters K010880 - High Pressure Catheter (Marauder) K952984 - Multi-Track Angiographic Catheter K030589 - Tyshak II and Z-MED II Catheters K032591 - Tyshak Mini Pediatric Catheter K014124 - COEfficient PTV Catheter…
NuMED, Inc.2003—
*K032591Numed Tyshak Mini Pediatric PTV Catheter
Summary page 1
…PTA Catheters K010880 - High Pressure Catheter (Marauder) K952984 - Multi-Track Angiographic Catheter K030589 - Tyshak II and Z-MED II Catheters K032591 - Tyshak Mini Pediatric Catheter K014124 - COEfficient PTV Catheter K003320 - PTS Sizing Balloon Catheter K0136…
NuMED, Inc.2003—
*K014124Numed Coefficient PTV Catheters
Summary page 1
…theter (Marauder) K952984 - Multi-Track Angiographic Catheter K030589 - Tyshak II and Z-MED II Catheters K032591 - Tyshak Mini Pediatric Catheter K014124 - COEfficient PTV Catheter K003320 - PTS Sizing Balloon Catheter K013601 - Mullins PTA Catheter K011557 - 'Y' C…
NuMED, Inc.2002—
*K003320Pta-OS Sizing Balloon, Model 360
Summary page 1
…rack Angiographic Catheter K030589 - Tyshak II and Z-MED II Catheters K032591 - Tyshak Mini Pediatric Catheter K014124 - COEfficient PTV Catheter K003320 - PTS Sizing Balloon Catheter K013601 - Mullins PTA Catheter K011557 - 'Y' Change Submission K022722 - X line o…
NuMED, Inc.2001—
*K013601Numed Mullins Pta Catheter
Summary page 1
…yshak II and Z-MED II Catheters K032591 - Tyshak Mini Pediatric Catheter K014124 - COEfficient PTV Catheter K003320 - PTS Sizing Balloon Catheter K013601 - Mullins PTA Catheter K011557 - 'Y' Change Submission K022722 - X line of Catheters (Tyshak X, Tyshak II X, Z-MED X,…
NuMED, Inc.2002—
*K011557Pta, PTV, Atrioseptostomy, Angiographic, Sizing Catheters
Summary page 1
…K032591 - Tyshak Mini Pediatric Catheter K014124 - COEfficient PTV Catheter K003320 - PTS Sizing Balloon Catheter K013601 - Mullins PTA Catheter K011557 - 'Y' Change Submission K022722 - X line of Catheters (Tyshak X, Tyshak II X, Z-MED X, Z-MED II X, and Mullins X)…
NuMED, Inc.2001—
*K022722Pta and PTV
Summary page 1
…ter K014124 - COEfficient PTV Catheter K003320 - PTS Sizing Balloon Catheter K013601 - Mullins PTA Catheter K011557 - 'Y' Change Submission K022722 - X line of Catheters (Tyshak X, Tyshak II X, Z-MED X, Z-MED II X, and Mullins X)…
NuMED, Inc.2002—

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K153069Edwards Balloon CatheterEdwards Lifesciences20160

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 11 years and passes through 1 company; a new generation was cleared every 6.8 years on median.
  • 2 of the 19 ancestors have a recall of any class.
  • Of its descendants, K153069 (Edwards Lifesciences, 2016) has gone furthest, with 0 descendants of its own.

How does its category compare?

All DQO devices

DQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQO

2in 2025

2007: 82008: 32009: 82010: 72011: 62012: 152013: 22014: 32015: 102016: 42017: 102018: 102019: 62020: 32021: 12022: 42023: 42024: 42025: 22026 (partial year): 3
2007high 15 (2012) · low 1 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQO

148in 2024

2007: 106 days median2008: 80 days median2009: 58 days median2010: 137 days median2011: 74 days median2012: 94 days median2014: 109 days median2015: 209 days median2016: 89 days median2017: 176 days median2018: 234 days median2019: 113 days median2020: 30 days median2022: 181 days median2023: 73 days median2024: 148 days median2026 (partial year): 85 days median
2007high 234 (2018) · low 30 (2020)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DQO

1in 2023

2007: 142008: 42009: 72010: 112011: 72012: 22013: 12015: 1, 1 Class I2016: 2, 1 Class I2017: 12018: 22019: 712020: 4, 4 Class I2022: 12023: 1, 1 Class I2026 (partial year): 24, 4 Class I
2007high 71 (2019) · low 0 (2014)2026

Class I (11 since 2007) Class II/III not classified

Adverse event reports per year · DQO

656in 2025

2007: 5642008: 7262009: 9332010: 5562011: 6252012: 5322013: 7532014: 6012015: 6282016: 6142017: 8732018: 7772019: 3862020: 3122021: 3382022: 3792023: 3912024: 5112025: 656
2007high 933 (2009) · low 312 (2020)2025

MAUDE reports naming product code DQO, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007810614564
20083804726
20098587933
2010713711556
20116747625
201215942532
20132—1753
201431090601
2015102091 (1)628
20164892 (1)614
2017101761873
2018102342777
2019611371386
20203304 (4)312
20211—0338
202241811379
20234731 (1)391
202441480511
20252—0656
202638524 (4)—

What is it indicated for?

Multi-Track Angiopraphic Catheter (K952984, K003902) - Recommended for use in catheterization for angiography of cardiovascular vessels and/or chambers. It can be used for injection of contrast medium and pressure measurement in any chamber or vessel. Ghost II PTA (K003972, K011557) - This catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, iliac, and renal arteries. These catheters are not designed to be used in the…

Read the full statement (820 words)

Multi-Track Angiopraphic Catheter (K952984, K003902) - Recommended for use in catheterization for angiography of cardiovascular vessels and/or chambers. It can be used for injection of contrast medium and pressure measurement in any chamber or vessel.

Ghost II PTA (K003972, K011557) - This catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, iliac, and renal arteries. These catheters are not designed to be used in the coronary arteries.

Z-MED Catheter (K991977, K003114, K003643, K011557) - This catheter is recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve.

• A patient with isolated pulmonary stenosis

• A patient with valvular pulmonary stenosis with other minor congenital heart disease that does not require surgical intervention. And;

(K931009, K011557) This catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, iliac, and renal arteries. These catheters are not designed to be used in the coronary arteries.

Tyshak Mini Pediatric PTV Catheter (K003276, K011557, K032591) - This catheter is recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve in Pediatric applications.

* A patient with isolated pulmonary stenosis.

* A patient with valvular pulmonary stenosis with other minor congenital heart disease that does not require surgical intervention.

Tyshak Catheter (K991977, K003114, K011557) - This catheter is recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve.

A patient with isolated pulmonary stenosis

A patient with valvular pulmonary stenosis with other minor congenital heart disease that does not require surgical intervention. And;

(K931009, K011557) This catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, iliac, and renal arteries. These catheters are not designed to be used in the coronary arteries.

Tyshak II Catheter (K003052, K011557, K030589) - This catheter is recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve.

• A patient with isolated pulmonary stenosis

*A patient with valvular pulmonary stenosis with other minor congenital heart disease that does not require surgical intervention. And;

Z-MED II Catheter (K003052, K011557, K030589) - This catheter is recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve.

* A patient with isolated pulmonary stenosis

*A patient with valvular pulmonary stenosis with other minor congenital heart disease that does not require surgical intervention. And;

High Pressure PTA (Marauder) (K010880, K011557) - This iliac, catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, iliac, and renal arteries. These catheters are not designed to be used in the coronary arteries.

Z-5 Atrioseptostomy (K960070, K011557) - Used for the palliation of several congenital heart defects: transposition of the great arteries, total anomalous pulmonary venous drainage without pulmonary obstruction, tricuspid atresia, mitral stenosis, mitral atresia, and pulmonary atresia with intact ventricular septum.

Z-5 Braided Atrioseptostomy (K001804, K011557) - Used for the palliation of several congenital heart defects: transposition of the great arteries, total anomalous pulmonary venous drainage without pulmonary obstruction, tricuspid atresia, mitral stenosis, mitral atresia, and pulmonary atresia with intact ventricular septum.

Tyshak X Catheter (K022722)- This catheter is recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve.

* A patient with isolated pulmonary stenosis

* A patient with valvular pulmonary stenosis with other minor congenital heart disease that does not require surgical intervention.

Tyshak II X Catheter (K022722) - This catheter is recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve.

• A patient with isolated pulmonary stenosis

• A patient with valvular pulmonary stenosis with other minor congenital heart disease that does not require surgical intervention.

Z-MED X Catheter (K022722)- This catheter is recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve.

• A patient with isolated pulmonary stenosis

* A patient with valvular pulmonary stenosis with other minor congenital heart disease that does not require surgical intervention.

Z-MED II X Catheter (K022722) - This catheter is recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve.

A patient with isolated pulmonary stenosis

A patient with valvular pulmonary stenosis with other minor congenital heart disease that does not require surgical intervention.

COEfficient Catheter (K014124) - This catheter is recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve.

A patient with isolated pulmonary stenosis

A patient with valvular pulmonary stenosis with other minor congenital heart disease that does not require surgical intervention.

Ghost PTA (K931009, K011557) - This catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, iliac, and renal arteries. These catheters are not designed to be used in the coronary arteries.

Mullins PTA (K013601) - This catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, iliac, and renal arteries. These catheters are not designed to be used in the coronary arteries.

Mullins X PTA (K022722) - This catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, iliac, and renal arteries. These catheters are not designed to be used in the coronary arteries.

PTS (K003320, K011557) - For use in those patients with cardiovascular defects wherein accurate measurement of the defect is important to select the appropriately sized occluder device.

Indications for use as stated in the FDA summary.

More from NuMED, Inc.

57 FDA decisions under this applicant name. See the company

  • P150028/S007CP Stent (Model 425), Covered CP Stent (Model 427), Mounted CP Stent (Model 426), Covered and Mounted CP…NuMED, Inc. · 2026
  • K213915BIB Stent Placement CatheterNuMED, Inc. · 2022
  • P150028/S006G-Armor Stent, G-Armor Covered Stent, G-Armor Mounted Stent, G-Armor Covered Mounted StentNuMED, Inc. · 2021
  • P150028/S005NuDEL Delivery SystemNuMED, Inc. · 2021
  • K211910Z-6 Atrioseptostomy CatheterNuMED, Inc. · 2021

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The DQO category page

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https://510kreport.com/device/K040830 · printed Nov 6, 2026

Cite this page

510(k) Report. “K040830: Pta, PTV, Atrioseptostomy, Angiographic, Sizing Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040830

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026