510(k) · Cleared
ClearedPowerflex Pro Percutaneous Transluminal Angioplasty Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cordis Corp. · LIT Catheter, Angioplasty, Peripheral, Transluminal
Cleared on May 4, 2012 as substantially equivalent to K032737 (Cordis Europa, N.V., 2003) and 2 other predicates after a 221-day review. Its family tree reaches back 6 generations to 2000. 10 later devices descend from it.
- Decided
- May 4, 2012
- Review
- 221 days
- Class
- Class II
- Product code
- LIT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K001134 (2000). 16 ancestors in all, the oldest K971448 (1997). 10 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK001134 Gazelle Balloon Dilatation CatheterBoston Scientific Corp · 2000
- 5 generations backK021735 Boston Scientific Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Scimed, Inc. · 2002 · Recalled
- 4 generations backK050389 Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Corp · 2005
- 3 generations backK053118 Sterling Monorail Pta Balloon Dilatation Catheter, Model…Boston Scientific Corp · 2005
- 2 generations backK063563 Cordis Amila Percutaneous Transluminal Angioplasty (Pta) Balloon…Cordis Europa, N.V. · 2007
- 1 generation backK071189 Cordis Aviator Plus Pta Balloon Dilatation CatheterCordis Europa, N.V. · 2007
- This deviceK112797 Powerflex Pro Percutaneous Transluminal Angioplasty CatheterCordis Corp. · 2012
- Descendant · cites it directly · 9 of its ownK121442 Powerflex Pro Percutaneous Transluminal Angioplasty CatheterCordis Corporation · 2012 · Recalled
- Descendant · 2 generations on · 6 of its ownK133843 Saber Percutaneous Transluminal Angioplasty Dilatation CatheterCordis Corporation · 2014 · Recalled
- Descendant · 3 generations on · 4 of its ownK151153 Pirouette 018Arravasc Limited · 2015
- Descendant · 4 generations on · 2 of its ownK162316 Pirouette 014Arravasc, Ltd. · 2016
- Descendant · 4 generations on · 2 of its ownK161427 Pirouette 035Arravasc Limited · 2016
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K121442Powerflex Pro Percutaneous Transluminal Angioplasty CatheterCordis Corporation · 2012 · cites it directly9descendants
- K133843Saber Percutaneous Transluminal Angioplasty Dilatation CatheterCordis Corporation · 2014 · 2 generations on6descendants
- K151153Pirouette 018Arravasc Limited · 2015 · 3 generations on4descendants
- K162316Pirouette 014Arravasc, Ltd. · 2016 · 4 generations on2descendants
- K161427Pirouette 035Arravasc Limited · 2016 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K001134 | Gazelle Balloon Dilatation Catheter | Boston Scientific Corp | 2000 | — |
| −5 | K021735 | Boston Scientific Ultra-Soft SV Balloon Dilatation Catheter | Boston Scientific Scimed, Inc. | 2002 | 23 |
| −4 | K050389 | Ultra-Soft SV Balloon Dilatation Catheter | Boston Scientific Corp | 2005 | — |
| −3 | K053118 | Sterling Monorail Pta Balloon Dilatation Catheter, Model H74939031-Xxxxxx | Boston Scientific Corp | 2005 | — |
| −2 | K063563 | Cordis Amila Percutaneous Transluminal Angioplasty (Pta) Balloon Dilatation… | Cordis Europa, N.V. | 2007 | — |
| −1 | K071189 | Cordis Aviator Plus Pta Balloon Dilatation Catheter | Cordis Europa, N.V. | 2007 | — |
| 0 (this device) | K112797 | Powerflex Pro Percutaneous Transluminal Angioplasty Catheter | Cordis Corp. | 2012 | — |
| +1 | K121442 | Powerflex Pro Percutaneous Transluminal Angioplasty Catheter | Cordis Corporation | 2012 | 2 |
| +2 | K133843 | Saber Percutaneous Transluminal Angioplasty Dilatation Catheter | Cordis Corporation | 2014 | 1 |
| +3 | K151153 | Pirouette 018 | Arravasc Limited | 2015 | — |
| +4 | K162316 | Pirouette 014 | Arravasc, Ltd. | 2016 | — |
| +4 | K161427 | Pirouette 035 | Arravasc Limited | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
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 LIT? 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 LIT device
- #1 K241040 Amethyst HP PTA OTW 0.035 Catheterscore 13.9 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K032737 | Cordis Powerflex Extreme Pta Balloon Catheter, Cordis Powerflex Plus Pta Balloon…Summary page 1…Code Number (if multiple predicates) Powerflex'Tm Extreme Cordis LIT K032737 Design, Materials, PowerflexTM P3 & OPTATM PRO Corporation Construction, P… | 2003 |
| * | K071189 | Cordis Aviator Plus Pta Balloon Dilatation CatheterSummary page 3…ally equivalent to the Cordis Powerflex'TM P3 and OptaTM Pro Percutaneous Transluminal Angioplasty Catheters (K032737), Aviator Plus PTA Balloon Dilatation Catheter (K071189) and ClearStream Savvy Long PTA Catheter (K(072947). DEPARTMENT OF HEALTH & HUMAN SERVICES… | 2007 |
| * | K072947 | Savvy Long and Sleek Peripheral Transluminal Angioplasty (Pta) CathetersSummary page 1…ilatation Catheter Corporation ____ ___ _ _____________ Savvy Long and Sleek PTA Clearstreamn LIT K072947 Dimensions - longer lengths ICatheters ITechnologies, Ltd. I____ 1____ 1_(120 x 220… | 2008 |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121442 | Powerflex Pro Percutaneous Transluminal Angioplasty Catheter | 2012 | 9 |
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 12 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 2 of the 16 ancestors have a recall of any class.
- Of its descendants, K121442 (Cordis Corporation, 2012) has gone furthest, with 9 descendants of its own.
- 3 other devices also cite its predicate K032737.
How does its category compare?
All LIT devicesLIT Catheter, Angioplasty, Peripheral, Transluminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · LIT
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LIT
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LIT
1in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · LIT
2,073in 2025
MAUDE reports naming product code LIT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 6 | 64 | 0 | 577 |
| 2008 | 8 | 53 | 0 | 513 |
| 2009 | 7 | 29 | 2 | 623 |
| 2010 | 13 | 78 | 1 | 809 |
| 2011 | 10 | 82 | 0 | 857 |
| 2012 | 19 | 29 | 0 | 1,277 |
| 2013 | 14 | 79 | 2 (2) | 1,242 |
| 2014 | 12 | 90 | 3 | 1,178 |
| 2015 | 19 | 112 | 0 | 1,279 |
| 2016 | 11 | 116 | 1 | 1,529 |
| 2017 | 9 | 57 | 0 | 2,081 |
| 2018 | 6 | 118 | 2 | 2,188 |
| 2019 | 4 | 40 | 3 | 2,405 |
| 2020 | 9 | 125 | 0 | 2,443 |
| 2021 | 4 | 61 | 1 | 2,492 |
| 2022 | 8 | 122 | 0 | 2,155 |
| 2023 | 6 | 167 | 0 | 1,807 |
| 2024 | 6 | 43 | 2 | 1,913 |
| 2025 | 3 | 90 | 1 | 2,073 |
| 2026 | 4 | 205 | 0 | — |
What is it indicated for?
The PowerflexM Pro PTA catheter is intended to dilate stenoses in iliac, femoral, ilia-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device is also indicated for post-dilatation of balloon-expandable and self-expanding stents in the peripheral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112797 · printed Nov 3, 2026
Cite this page
510(k) Report. “K112797: Powerflex Pro Percutaneous Transluminal Angioplasty Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K112797
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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