510(k) Report

510(k) · Cleared

Recalled · Class II · 2020

Cordis Powerflex Extreme Pta Balloon Catheter, Cordis Powerflex Plus Pta Balloon Catheter, Cordis Powerflex P3 Pta

K032737510(k) SpecialCleared Oct 2, 200328-day reviewClass II21 CFR 870.1250Recalls 1

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

Cordis Europa, N.V. · DQY Catheter, Percutaneous

Cleared on Oct 2, 2003 after a 28-day review. The FDA summary names no predicate by number. 17 later devices descend from it. It has been recalled once.

Decided
Oct 2, 2003
Review
28 days
Class
Class II
Product code
DQY
Recalls
1
Predicates
0

17 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2008: 1 descendant cleared2012: 3 descendants cleared2009: 1 descendant cleared2007: 1 descendant cleared2013: 1 descendant cleared2020: 2 descendants cleared2014: 1 descendant cleared2015: 1 descendant cleared2022: 1 descendant cleared2021: 1 descendant cleared2017: 1 descendant cleared2016: 2 descendants cleared2019: 1 descendant cleared200020052010201520202025
  1. This deviceK032737 Cordis Powerflex Extreme Pta Balloon Catheter, Cordis Powerflex Plus…Cordis Europa, N.V. · 2003
  2. Descendant · cites it directly · 10 of its ownK112797 Powerflex Pro Percutaneous Transluminal Angioplasty CatheterCordis Corp. · 2012
  3. Descendant · 2 generations on · 9 of its ownK121442 Powerflex Pro Percutaneous Transluminal Angioplasty CatheterCordis Corporation · 2012 · Recalled
  4. Descendant · 3 generations on · 6 of its ownK133843 Saber Percutaneous Transluminal Angioplasty Dilatation CatheterCordis Corporation · 2014 · Recalled
  5. Descendant · 4 generations on · 4 of its ownK151153 Pirouette 018Arravasc Limited · 2015
  6. Descendant · cites it directly · 3 of its ownK092361 Reef HP 0.035 Otw Pta Balloon Dilatation CatheterInvatec S.P.A. · 2009

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

2007: 12008: 12009: 12012: 32013: 12014: 12015: 12016: 22017: 12019: 12020: 22021: 12022: 1
2007high 3 (2012) · low 0 (2010)2026

Most influential descendants

Showing 5 of 17 · See all
  • K112797Powerflex Pro Percutaneous Transluminal Angioplasty CatheterCordis Corp. · 2012 · cites it directly10descendants
  • K121442Powerflex Pro Percutaneous Transluminal Angioplasty CatheterCordis Corporation · 2012 · 2 generations on9descendants
  • K133843Saber Percutaneous Transluminal Angioplasty Dilatation CatheterCordis Corporation · 2014 · 3 generations on6descendants
  • K151153Pirouette 018Arravasc Limited · 2015 · 4 generations on4descendants
  • K092361Reef HP 0.035 Otw Pta Balloon Dilatation CatheterInvatec S.P.A. · 2009 · cites it directly3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K032737Cordis Powerflex Extreme Pta Balloon Catheter, Cordis Powerflex Plus Pta…Cordis Europa, N.V.2003—
+1K112797Powerflex Pro Percutaneous Transluminal Angioplasty CatheterCordis Corp.2012—
+2K121442Powerflex Pro Percutaneous Transluminal Angioplasty CatheterCordis Corporation20122
+3K133843Saber Percutaneous Transluminal Angioplasty Dilatation CatheterCordis Corporation20141
+4K151153Pirouette 018Arravasc Limited2015—
+1K092361Reef HP 0.035 Otw Pta Balloon Dilatation CatheterInvatec S.P.A.2009—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200810
200910
201230
201310
201410
201510
201620
201710
201910
202020
202110
202210
FIG. 1 — Lineage of K032737, 2003–2022Source: 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?

The FDA summary names no predicate by number.

What descends from it? (17)

See all 17

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

NumberDeviceApplicantDecidedDescendants
K112797Powerflex Pro Percutaneous Transluminal Angioplasty CatheterCordis Corp.201210
K092361Reef HP 0.035 Otw Pta Balloon Dilatation CatheterInvatec S.P.A.20093
K072156Optimus 0.035 Inch Pta Balloon Dilatation CatheterUsci Ireland20071
K082646Optimus 0.035 Pta Balloon Dilatation CatheterUsci Ireland20080

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

Recalls of this device

DateClassRecallRoot causeReason
Jan 8, 2020Class IIZ-1477-2020PendingCordis is recalling one (1) lot of POWERFLEX P3 PTA Dilatation Catheter due to the potential for body/shaft voids in the proximal seal area.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K112797 (Cordis Corp., 2012) has gone furthest, with 10 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?

The POWERFLEX EXTREME PTA catheter is intended for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae and to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries. The POWERFLEX P3 PTA catheter is intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic…

Read the full statement (102 words)

The POWERFLEX EXTREME PTA catheter is intended for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae and to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries.

The POWERFLEX P3 PTA catheter is intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The OPTA PRO PTA catheter is intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Indications for use as stated in the FDA summary.

More from Cordis Europa, N.V.

7 FDA decisions under this applicant name. See the company

  • K071189Cordis Aviator Plus Pta Balloon Dilatation CatheterCordis Europa, N.V. · 2007
  • K063563Cordis Amila Percutaneous Transluminal Angioplasty (Pta) Balloon Dilatation CatheterCordis Europa, N.V. · 2007
  • K060302Inscope Precision Balloon Dilator - Wire GuidedCordis Europa, N.V. · 2006
  • K043605Inscope 3-Stage Balloon DilatorCordis Europa, N.V. · 2005
  • K040413Cordis Palmaz Blue Transhepatic Biliary Stent on Slalom .018 Delivery SystemCordis Europa, N.V. · 2004

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/K032737 · printed Nov 6, 2026

Cite this page

510(k) Report. “K032737: Cordis Powerflex Extreme Pta Balloon Catheter, Cordis Powerflex Plus Pta Balloon Catheter, Cordis Powerflex P3 Pta.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032737

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