510(k) Report

510(k) · Cleared

Cleared

Alvision Interventional Cardiology Diagnostic Catheter, Alvicath Endovascular Diagnostic Catheters

K143604510(k) TraditionalCleared Jun 25, 2015189-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

Alvimedica Tibbi Urunler Sanayi VE Dis Ticaret A.S · DQO Catheter, Intravascular, Diagnostic

Cleared on Jun 25, 2015 as substantially equivalent to K943739 (Mallinckrodt Medical, 1994) and 1 other predicate after a 189-day review. Its family tree reaches back 1 generation to 1994.

Decided
Jun 25, 2015
Review
189 days
Class
Class II
Product code
DQO
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K943739 (1994). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2000: 1 other ancestorK943739 · Softouch Diagnostic Intravascular Catheter · Mallinckrodt Medical · 1994 · recalled199019952000200520102015
Other ancestors, by generation 1 generation back: 1 other ancestor K943739 · Softouch Diagnostic Intravascular Catheter · Mallinckrodt Medical · 1994 · recalled0
  1. Root · 1 generation backK943739 Softouch Diagnostic Intravascular CatheterMallinckrodt Medical · 1994 · Recalled
  2. This deviceK143604 Alvision Interventional Cardiology Diagnostic Catheter, Alvicath…Alvimedica Tibbi Urunler Sanayi VE Dis Ticaret A.S · 2015
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K943739Softouch Diagnostic Intravascular CatheterMallinckrodt Medical19944
0 (this device)K143604Alvision Interventional Cardiology Diagnostic Catheter, Alvicath Endovascular…Alvimedica Tibbi Urunler Sanayi VE Dis Ticaret A.S2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010
FIG. 1 — Lineage of K143604, 1994–2015Source: 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
Get a 510(k) Report

What was it cleared against? (2)

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
*K943739Softouch Diagnostic Intravascular Catheter
Summary page 5
…Page 2 of 4 510(k) SUMMARY III. PREDICATE DEVICES [807.92(a)(3)] • Merit Medical Performa (Softouch) Angiography Catheters (K943739; K000659) No reference devices were used in this submission. IV. DEVICE DESCRIPTION [807.92(a)(4)]…
Mallinckrodt Medical19944
*K000659Modification to Softouch Diagnostic Intravascular Cat
Summary page 5
…Page 2 of 4 510(k) SUMMARY III. PREDICATE DEVICES [807.92(a)(3)] • Merit Medical Performa (Softouch) Angiography Catheters (K943739; K000659) No reference devices were used in this submission. IV. DEVICE DESCRIPTION [807.92(a)(4)] The Alvision™ Inte…
Merit Medical Systems, Inc.20001

Also cleared against K943739: 4 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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?

  • 2 of the 2 ancestors have a recall of any class.
  • 4 other devices also cite its predicate K943739.

How does its category compare?

All DQO devices

DQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

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?

Alvision™ Interventional Cardiology Diagnostic Catheters are intended for use in the delivery of radio-opaque media to selected sites in the coronary vascular system.

Alvicath™ Endovascular Diagnostic Catheters are intended for use in the delivery of radio-opaque media to selected sites in the peripheral vascular system.

Indications for use as stated in the FDA summary.

Also cleared against K943739

4 other devices cite the same predicate.

  • K113819Mongoose Angiographic CatheterPediacath, Inc. · 2012
  • K051395Langston Dual Lumen Pressure Monitoring CatheterVascular Solutions, Inc. · 20055 Class I recalls
  • K050168Langston Dual Lumen Pressure Monitoring CatheterVascular Solutions, Inc. · 2005
  • K041909Vascular Solutions Langston Dual Lumen Pigtail Catheter (DLP)Vascular Solutions, Inc. · 2004

More from Alvimedica Tibbi Urunler Sanayi VE Dis…

2 FDA decisions under this applicant name. See the company

  • K141529Alviguide Blue+ Interventional Cardiology Guiding CatheterAlvimedica Tibbi Urunler Sanayi VE Dis Ticaret A.S · 2014

Recent decisions in DQO

The DQO category page

  • K261455Arterial Pressure Monitoring Set/TraySpectrum Vascular · 2026
  • K252702Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF…Bioptimal International Pte., Ltd. · 2026
  • K254278Arterial Pressure Monitoring Set/TraySpectrum Vascular · 2026
  • K250751DualView CatheterTerumo Corporation · 2025
  • K242966Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging CatheterGentuity, LLC · 20251 recall

https://510kreport.com/device/K143604 · printed Nov 4, 2026

Cite this page

510(k) Report. “K143604: Alvision Interventional Cardiology Diagnostic Catheter, Alvicath Endovascular Diagnostic Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K143604

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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