510(k) · Cleared
Recalled · Class II · 2016Powercross .018 Otw Pta Dilation Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ev3, Inc. · LIT Catheter, Angioplasty, Peripheral, Transluminal
Cleared on Nov 13, 2009 as substantially equivalent to K090849 (Ev3, Inc., 2009) and 1 other predicate after a 24-day review. Its family tree reaches back 6 generations to 2000. 14 later devices descend from it. It has been recalled 2 times.
- Decided
- Nov 13, 2009
- Review
- 24 days
- Class
- Class II
- Product code
- LIT
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 6 generations to K001134 (2000). 16 ancestors in all. 14 later devices descend from it, 5 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 backK053116 Sterling Otw Pta Balloon Dilatation Catheter, Model H74939032-XxxxxxBoston Scientific Corp · 2005
- 2 generations backK072283 Dorado Pta Balloon Dilatation CatheterBard Peripheral Vascular, Inc. · 2007 · Recalled
- 1 generation backK082579 Evercross .035 Otw Pta Dilatation CatheterEv3, Inc. · 2008 · Recalled
- This deviceK093286 Powercross .018 Otw Pta Dilation CatheterEv3, Inc. · 2009
- Descendant · cites it directly · 8 of its ownK123544 Rapidcross Pta Rapid Exchange, Balloon Dilatation CatheterEv3, Inc. · 2013
- Descendant · cites it directly · 7 of its ownK130911 Rapidcross Pta Rapid Exchange Balloon Dilatation CatheterEv3, Inc. · 2013
- Descendant · 2 generations on · 6 of its ownK132777 Nanocross Elite .14 Over-the-Wire Pta, Balloon Dilation CatheterEv3, Inc. · 2013
- Descendant · cites it directly · 5 of its ownK141118 Nanocross Eite 0.014 Over-the-Wire Pta Balloon Dilatation CatheterEv3, Inc. · 2014 · Recalled
- Descendant · cites it directly · 2 of its ownK160004 Crosstella OTWKANEKA Corporation · 2016
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K123544Rapidcross Pta Rapid Exchange, Balloon Dilatation CatheterEv3, Inc. · 2013 · cites it directly8descendants
- K130911Rapidcross Pta Rapid Exchange Balloon Dilatation CatheterEv3, Inc. · 2013 · cites it directly7descendants
- K132777Nanocross Elite .14 Over-the-Wire Pta, Balloon Dilation CatheterEv3, Inc. · 2013 · 2 generations on6descendants
- K141118Nanocross Eite 0.014 Over-the-Wire Pta Balloon Dilatation CatheterEv3, Inc. · 2014 · cites it directly5descendants
- K160004Crosstella OTWKANEKA Corporation · 2016 · cites it directly2descendants
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 | K053116 | Sterling Otw Pta Balloon Dilatation Catheter, Model H74939032-Xxxxxx | Boston Scientific Corp | 2005 | — |
| −2 | K072283 | Dorado Pta Balloon Dilatation Catheter | Bard Peripheral Vascular, Inc. | 2007 | 15 |
| −1 | K082579 | Evercross .035 Otw Pta Dilatation Catheter | Ev3, Inc. | 2008 | 1 |
| 0 (this device) | K093286 | Powercross .018 Otw Pta Dilation Catheter | Ev3, Inc. | 2009 | — |
| +1 | K123544 | Rapidcross Pta Rapid Exchange, Balloon Dilatation Catheter | Ev3, Inc. | 2013 | — |
| +1 | K130911 | Rapidcross Pta Rapid Exchange Balloon Dilatation Catheter | Ev3, Inc. | 2013 | — |
| +2 | K132777 | Nanocross Elite .14 Over-the-Wire Pta, Balloon Dilation Catheter | Ev3, Inc. | 2013 | — |
| +1 | K141118 | Nanocross Eite 0.014 Over-the-Wire Pta Balloon Dilatation Catheter | Ev3, Inc. | 2014 | 1 |
| +1 | K160004 | Crosstella OTW | KANEKA Corporation | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 4 | 0 |
| 2020 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K090849 | Modification to: Nanocross 0.14 Otw Pta Dilatation Catheter, Models AB14W020210090…Summary page 1…duct Code DQY) Classification Panel Cardiovascular Predicate Device NanoCross'TM .0 14" OTW PTA Dilatation Catheter (K090849) EverCrossTM .035" OTW PTA Dilatation Catheter (K082579) Intended use… | 2009 |
| * | K082579 | Evercross .035 Otw Pta Dilatation CatheterSummary page 1…evice NanoCross'TM .0 14" OTW PTA Dilatation Catheter (K090849) EverCrossTM .035" OTW PTA Dilatation Catheter (K082579) Intended use The PowerCross .018" OTW PTA Dilatation Catheter is… | 2008 |
What descends from it? (14)
See all 145 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123544 | Rapidcross Pta Rapid Exchange, Balloon Dilatation Catheter | 2013 | 8 |
| K130911 | Rapidcross Pta Rapid Exchange Balloon Dilatation Catheter | 2013 | 7 |
| K141118 | Nanocross Eite 0.014 Over-the-Wire Pta Balloon Dilatation Catheter | 2014 | 5 |
| K160004 | Crosstella OTW | 2016 | 2 |
| K152873 | Crosstella RX Balloon Dilatation Catheter | 2016 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 10, 2016 | Class II | Z-0892-2017 | Process control | Medtronic identified an issue with specific models and lots of the PowerCross .018 Over the Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter. During an unrelated manufacturing inspection of scrapped products, an… |
| Mar 29, 2016 | Class II | Z-1552-2016 | Labeling False and Misleading | Medtronic is conducting a voluntary Urgent Medical Device Recall of two lots of the PowerCross 0.018" ¿ Over the Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter because the product is mislabeled. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
- 5 of the 16 ancestors have a recall of any class.
- Of its descendants, K123544 (Ev3, Inc., 2013) has gone furthest, with 8 descendants of its own.
- 8 other devices also cite its predicate K090849.
How does its category compare?
All LIT devicesLIT Catheter, Angioplasty, Peripheral, Transluminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 PowerCross .018" OTW PTA Dilatation Catheter is intended to dilate stenoses in the
iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the
treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
This device is also indicated for stent post-dilatation in the peripheral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093286 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093286: Powercross .018 Otw Pta Dilation Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093286
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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