510(k) Report

510(k) · Cleared

Cleared

Modification to Numed Tyshak II and Z-Med II PTV Catheters

K030589510(k) SpecialCleared May 21, 200385-day reviewClass II21 CFR 870.1250

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

NuMED, Inc. · DQY Catheter, Percutaneous

Cleared on May 21, 2003 after an 85-day review. The FDA summary names its predicate without a number. 14 later devices descend from it.

Decided
May 21, 2003
Review
85 days
Class
Class II
Product code
DQY
Recalls
None
Predicates
0

14 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2008: 2 descendants cleared2004: 1 descendant cleared2016: 1 descendant cleared2011: 1 descendant cleared2019: 3 descendants cleared2021: 1 descendant cleared2024: 1 descendant cleared2020: 2 descendants cleared2026: 2 descendants clearedReference device: K003052 · Numed Tyshak II and Z-Med II PTV Catheters · NuMED, Inc. · 2000Reference device: K931009 · Tyshak Peripheral Balloon Dilation Catheter · NuMED, Inc. · 1993 · recalledReference device: K991977 · Tyshak, Model 102 and Z-Med, Model 302 · NuMED, Inc. · 2000200020052010201520202025
  1. This deviceK030589 Modification to Numed Tyshak II and Z-Med II PTV CathetersNuMED, Inc. · 2003
  2. Descendant · cites it directly · 11 of its ownK073166 Endowave Infusion SystemEkos Corp. · 2008
  3. Descendant · 2 generations on · 10 of its ownK081467 Ekosonic Endovascular System with Rapid Pulse ModulationEkos Corp. · 2008 · Recalled
  4. Descendant · 3 generations on · 9 of its ownK111705 Ekosonic Endovascular SystemEkos Corporation · 2011 · Recalled
  5. Descendant · 4 generations on · 8 of its ownK183290 Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular…Thrombolex, Inc. · 2019
  6. Descendant · 5 generations on · 2 of its ownK192864 UNI*FUSE Infusion System with Cooper WireAngioDynamics, Inc. · 2020

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2004: 12008: 22011: 12016: 12019: 32020: 22021: 12024: 12026: 2
2004high 3 (2019) · low 0 (2005)2026

Most influential descendants

Showing 5 of 14 · See all
  • K073166Endowave Infusion SystemEkos Corp. · 2008 · cites it directly11descendants
  • K081467Ekosonic Endovascular System with Rapid Pulse ModulationEkos Corp. · 2008 · 2 generations on10descendants
  • K111705Ekosonic Endovascular SystemEkos Corporation · 2011 · 3 generations on9descendants
  • K183290Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200Thrombolex, Inc. · 2019 · 4 generations on8descendants
  • K192864UNI*FUSE Infusion System with Cooper WireAngioDynamics, Inc. · 2020 · 5 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K030589Modification to Numed Tyshak II and Z-Med II PTV CathetersNuMED, Inc.2003—
+1K073166Endowave Infusion SystemEkos Corp.2008—
+2K081467Ekosonic Endovascular System with Rapid Pulse ModulationEkos Corp.20085
+3K111705Ekosonic Endovascular SystemEkos Corporation20115
+4K183290Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter…Thrombolex, Inc.2019—
+5K192864UNI*FUSE Infusion System with Cooper WireAngioDynamics, Inc.2020—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200820
201110
201610
201930
202020
202110
202410
202620
FIG. 1 — Lineage of K030589, 2003–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 DQY? 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 DQY device

  1. #1 K234115 APRO 55 Catheterscore 17.5 · 6 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (1)

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
*—NuMED Tyshak and Z-MED PTV Catheters
Named without a submission number
—
†K003052Numed Tyshak II and Z-Med II PTV CathetersNuMED, Inc.2000—
†K931009Tyshak Peripheral Balloon Dilation CatheterNuMED, Inc.19931
†K991977Tyshak, Model 102 and Z-Med, Model 302NuMED, Inc.2000—

What descends from it? (14)

See all 14

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K073166Endowave Infusion SystemEkos Corp.200811
K040830Pta, PTV, Atrioseptostomy, Angiographic, Sizing CathetersNuMED, Inc.20041

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?

  • Of its descendants, K073166 (Ekos Corp., 2008) has gone furthest, with 11 descendants of its own.

How does its category compare?

All DQY devices

DQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQY

21in 2025

2007: 162008: 312009: 372010: 222011: 362012: 302013: 322014: 192015: 272016: 222017: 262018: 252019: 302020: 202021: 182022: 182023: 182024: 162025: 212026 (partial year): 11
2007high 37 (2009) · low 16 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQY

115in 2025

2007: 85 days median2008: 66 days median2009: 73 days median2010: 74 days median2011: 71 days median2012: 87 days median2013: 92 days median2014: 127 days median2015: 118 days median2016: 117 days median2017: 113 days median2018: 106 days median2019: 111 days median2020: 120 days median2021: 81 days median2022: 74 days median2023: 114 days median2024: 87 days median2025: 115 days median2026 (partial year): 30 days median
2007high 127 (2014) · low 66 (2008)2026

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

Recalls per year · DQY

1in 2025

2007: 62008: 122009: 172010: 322011: 62012: 22013: 36, 1 Class I2014: 32015: 32016: 22, 7 Class I2017: 82018: 22019: 12020: 22021: 22023: 172024: 12025: 1, 1 Class I2026 (partial year): 2, 1 Class I
2007high 36 (2013) · low 0 (2022)2026

Class I (10 since 2007) Class II/III not classified

Adverse event reports per year · DQY

3,056in 2025

2007: 3132008: 4962009: 8192010: 1,2932011: 1,2112012: 1,1912013: 1,3522014: 1,4972015: 2,3372016: 2,2522017: 2,4892018: 2,8552019: 2,9022020: 2,8892021: 3,0062022: 2,6432023: 3,0492024: 3,1902025: 3,056
2007high 3,190 (2024) · low 313 (2007)2025

MAUDE reports naming product code DQY, 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
200716856313
2008316612496
2009377317819
20102274321,293
2011367161,211
2012308721,191
2013329236 (1)1,352
20141912731,497
20152711832,337
20162211722 (7)2,252
20172611382,489
20182510622,855
20193011112,902
20202012022,889
2021188123,006
2022187402,643
202318114173,049
2024168713,190
2025211151 (1)3,056
202611302 (1)—

What is it indicated for?

This catheter is recommnded 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 requrie surgical intervention

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

Recent decisions in DQY

The DQY category page

  • K262817CrossFAST Integrated Microcatheter Advanced Delivery SystemVantis Vascular, Inc. · 2026
  • K260559NHanceITIMDS Operation B.V. · 2026
  • K262392APRO 35 Swift CatheterAlembic, LLC · 2026
  • K261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLC · 2026
  • K262240SSPC NXT Delivery CatheterCenterPoint Systems, LLC · 2026

https://510kreport.com/device/K030589 · printed Nov 4, 2026

Cite this page

510(k) Report. “K030589: Modification to Numed Tyshak II and Z-Med II PTV Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K030589

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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