510(k) · Cleared
Recalled · Class II · 2014Evercross .035 Otw Pta Dilatation Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ev3, Inc. · DQY Catheter, Percutaneous
Cleared on Nov 20, 2008 as substantially equivalent to K053116 (Boston Scientific Corp, 2005) and 3 other predicates after a 76-day review. Its family tree reaches back 5 generations to 2000. 35 later devices descend from it. It has been recalled once.
- Decided
- Nov 20, 2008
- Review
- 76 days
- Class
- Class II
- Product code
- DQY
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 5 generations to K001134 (2000). 13 ancestors in all. 35 later devices descend from it, 6 citing it directly.
- Root · 5 generations backK001134 Gazelle Balloon Dilatation CatheterBoston Scientific Corp · 2000
- 4 generations backK021735 Boston Scientific Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Scimed, Inc. · 2002 · Recalled
- 3 generations backK050389 Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Corp · 2005
- 2 generations backK053116 Sterling Otw Pta Balloon Dilatation Catheter, Model H74939032-XxxxxxBoston Scientific Corp · 2005
- 1 generation backK072283 Dorado Pta Balloon Dilatation CatheterBard Peripheral Vascular, Inc. · 2007 · Recalled
- This deviceK082579 Evercross .035 Otw Pta Dilatation CatheterEv3, Inc. · 2008
- Descendant · cites it directly · 14 of its ownK093286 Powercross .018 Otw Pta Dilation CatheterEv3, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 8 of its ownK123544 Rapidcross Pta Rapid Exchange, Balloon Dilatation CatheterEv3, Inc. · 2013
- Descendant · cites it directly · 8 of its ownK101062 Glider Pta Balloon CatheterTrireme Medical, Inc. · 2010
- Descendant · 2 generations on · 7 of its ownK130911 Rapidcross Pta Rapid Exchange Balloon Dilatation CatheterEv3, Inc. · 2013
- Descendant · 3 generations on · 6 of its ownK132777 Nanocross Elite .14 Over-the-Wire Pta, Balloon Dilation CatheterEv3, Inc. · 2013
Showing 5 of 35 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 35 · See all- K093286Powercross .018 Otw Pta Dilation CatheterEv3, Inc. · 2009 · cites it directly14descendants
- K123544Rapidcross Pta Rapid Exchange, Balloon Dilatation CatheterEv3, Inc. · 2013 · 2 generations on8descendants
- K101062Glider Pta Balloon CatheterTrireme Medical, Inc. · 2010 · cites it directly8descendants
- K130911Rapidcross Pta Rapid Exchange Balloon Dilatation CatheterEv3, Inc. · 2013 · 2 generations on7descendants
- K132777Nanocross Elite .14 Over-the-Wire Pta, Balloon Dilation CatheterEv3, Inc. · 2013 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K001134 | Gazelle Balloon Dilatation Catheter | Boston Scientific Corp | 2000 | — |
| −4 | K021735 | Boston Scientific Ultra-Soft SV Balloon Dilatation Catheter | Boston Scientific Scimed, Inc. | 2002 | 23 |
| −3 | K050389 | Ultra-Soft SV Balloon Dilatation Catheter | Boston Scientific Corp | 2005 | — |
| −2 | K053116 | Sterling Otw Pta Balloon Dilatation Catheter, Model H74939032-Xxxxxx | Boston Scientific Corp | 2005 | — |
| −1 | K072283 | Dorado Pta Balloon Dilatation Catheter | Bard Peripheral Vascular, Inc. | 2007 | 15 |
| 0 (this device) | K082579 | Evercross .035 Otw Pta Dilatation Catheter | Ev3, Inc. | 2008 | — |
| +1 | K093286 | Powercross .018 Otw Pta Dilation Catheter | Ev3, Inc. | 2009 | 2 |
| +2 | K123544 | Rapidcross Pta Rapid Exchange, Balloon Dilatation Catheter | Ev3, Inc. | 2013 | — |
| +1 | K101062 | Glider Pta Balloon Catheter | Trireme Medical, Inc. | 2010 | — |
| +2 | K130911 | Rapidcross Pta Rapid Exchange Balloon Dilatation Catheter | Ev3, Inc. | 2013 | — |
| +3 | K132777 | Nanocross Elite .14 Over-the-Wire Pta, Balloon Dilation Catheter | Ev3, Inc. | 2013 | — |
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 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 5 | 0 |
| 2012 | 3 | 0 |
| 2013 | 4 | 0 |
| 2014 | 2 | 0 |
| 2015 | 4 | 0 |
| 2016 | 7 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 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 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 K234115 APRO 55 Catheterscore 17.5 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K053116 | Sterling Otw Pta Balloon Dilatation Catheter, Model H74939032-XxxxxxSummary page 1…Product Code LIT Classification Panel Cardiovascular Predicate Devices Sterling OTW PTA Balloon Dilatation Catheter (K053 116), Admiral Xtreme PTA Balloon Catheter OTW .035 (K062809), Savvy Long and… | 2005 |
| * | K062809 | Admiral Xtreme Pta CatheterSummary page 1…ices Sterling OTW PTA Balloon Dilatation Catheter (K053 116), Admiral Xtreme PTA Balloon Catheter OTW .035 (K062809), Savvy Long and Sleek PTA Catheter (K072947), and Dorado PTA Balloon Dilatation… | 2006 |
| * | K072947 | Savvy Long and Sleek Peripheral Transluminal Angioplasty (Pta) CathetersSummary page 1…Xtreme PTA Balloon Catheter OTW .035 (K062809), Savvy Long and Sleek PTA Catheter (K072947), and Dorado PTA Balloon Dilatation Catheter (K072283). Intended use… | 2008 |
| * | K072283 | Dorado Pta Balloon Dilatation CatheterSummary page 1…and Sleek PTA Catheter (K072947), and Dorado PTA Balloon Dilatation Catheter (K072283). Intended use The EverCross .035" OTW PTA Dilatation Catheter is intended to… | 2007 |
What descends from it? (35)
See all 356 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093286 | Powercross .018 Otw Pta Dilation Catheter | 2009 | 14 |
| K101062 | Glider Pta Balloon Catheter | 2010 | 8 |
| K103534 | Gliderxtreme Pta Balloon Catheter (CB) (Over the Wire) 0.014 / 0.018 Guide Wire | 2011 | 6 |
| K110319 | Evercross 0.035 Otw Pta Dilatation Catheter | 2011 | 5 |
| K150865 | Metacross RX PTA Balloon Dilitation Catheter | 2015 | 4 |
| K152080 | Metacross OTW PTA Balloon Dilatation Catheter | 2015 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 9, 2014 | Class II | Z-1489-2014 | Labeling Change Control | Covidien is recalling 2 production lots of EverCross 0.035 PTA Balloon Catheter because of a product labeling error. There is a discrepancy in the PTA Balloon length and the delivery catheter length printed on the product labeling. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
- 2 of the 13 ancestors have a recall of any class.
- Of its descendants, K093286 (Ev3, Inc., 2009) has gone furthest, with 14 descendants of its own.
- 5 other devices also cite its predicate K053116.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · DQY
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQY
115in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQY
1in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · DQY
3,056in 2025
MAUDE reports naming product code DQY, 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 | 16 | 85 | 6 | 313 |
| 2008 | 31 | 66 | 12 | 496 |
| 2009 | 37 | 73 | 17 | 819 |
| 2010 | 22 | 74 | 32 | 1,293 |
| 2011 | 36 | 71 | 6 | 1,211 |
| 2012 | 30 | 87 | 2 | 1,191 |
| 2013 | 32 | 92 | 36 (1) | 1,352 |
| 2014 | 19 | 127 | 3 | 1,497 |
| 2015 | 27 | 118 | 3 | 2,337 |
| 2016 | 22 | 117 | 22 (7) | 2,252 |
| 2017 | 26 | 113 | 8 | 2,489 |
| 2018 | 25 | 106 | 2 | 2,855 |
| 2019 | 30 | 111 | 1 | 2,902 |
| 2020 | 20 | 120 | 2 | 2,889 |
| 2021 | 18 | 81 | 2 | 3,006 |
| 2022 | 18 | 74 | 0 | 2,643 |
| 2023 | 18 | 114 | 17 | 3,049 |
| 2024 | 16 | 87 | 1 | 3,190 |
| 2025 | 21 | 115 | 1 (1) | 3,056 |
| 2026 | 11 | 30 | 2 (1) | — |
What is it indicated for?
The EverCross 0.035" 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/K082579 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082579: Evercross .035 Otw Pta Dilatation Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082579
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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