510(k) · Cleared
ClearedEvercross 0.035 Otw Pta Dilatation 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 Apr 14, 2011 as substantially equivalent to K082579 (Ev3, Inc., 2008) and 1 other predicate after a 70-day review. Its family tree reaches back 6 generations to 2000. 5 later devices descend from it.
- Decided
- Apr 14, 2011
- Review
- 70 days
- Class
- Class II
- Product code
- LIT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K001134 (2000). 15 ancestors in all. 5 later devices descend from it, 4 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 deviceK110319 Evercross 0.035 Otw Pta Dilatation CatheterEv3, Inc. · 2011
- Descendant · cites it directly · 1 of its ownK151141 Cronus HP - High Pressure Peripheral Balloon CatheterNipro Medical Corporation · 2016
- Descendant · 2 generations on · 0 of its ownK190037 Cronus HP PTA Balloon CatheterNipro Medical Corporation · 2019
- Descendant · cites it directly · 0 of its ownK190753 EverCrossTM 0.035 OTW PTA Dilatation CatheterMedtronic, Inc. (Formerly D.B.A. Ev3, Inc. Covidien, LLC.) · 2019
- Descendant · cites it directly · 0 of its ownK142654 Fortrex 0.035 OTW PTA Balloon CatheterCovidien, LLC · 2014
- Descendant · cites it directly · 0 of its ownK111899 Armada 35/35LL Pta CatheterAbbott Vascular · 2011 · Recalled
Most influential descendants
Showing 5 of 5 · See all- K151141Cronus HP - High Pressure Peripheral Balloon CatheterNipro Medical Corporation · 2016 · cites it directly1descendant
- K190037Cronus HP PTA Balloon CatheterNipro Medical Corporation · 2019 · 2 generations on0descendants
- K190753EverCrossTM 0.035 OTW PTA Dilatation CatheterMedtronic, Inc. (Formerly D.B.A. Ev3, Inc. Covidien, LLC.) · 2019 · cites it directly0descendants
- K142654Fortrex 0.035 OTW PTA Balloon CatheterCovidien, LLC · 2014 · cites it directly0descendants
- K111899Armada 35/35LL Pta CatheterAbbott Vascular · 2011 · cites it directly0descendants
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) | K110319 | Evercross 0.035 Otw Pta Dilatation Catheter | Ev3, Inc. | 2011 | — |
| +1 | K151141 | Cronus HP - High Pressure Peripheral Balloon Catheter | Nipro Medical Corporation | 2016 | — |
| +2 | K190037 | Cronus HP PTA Balloon Catheter | Nipro Medical Corporation | 2019 | — |
| +1 | K190753 | EverCrossTM 0.035 OTW PTA Dilatation Catheter | Medtronic, Inc. (Formerly D.B.A. Ev3, Inc. Covidien, LLC.) | 2019 | — |
| +1 | K142654 | Fortrex 0.035 OTW PTA Balloon Catheter | Covidien, LLC | 2014 | — |
| +1 | K111899 | Armada 35/35LL Pta Catheter | Abbott Vascular | 2011 | 1 |
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 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 2 | 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 |
|---|---|---|---|
| * | K082579 | Evercross .035 Otw Pta Dilatation CatheterSummary page 1…3. Predicate Devices Device Trade Name EverCrossTM .035" OTW PTA Dilatation Catheter 510(k) Number K082579, K103322 510(k) Clearance Date November 20, 2008, December 6 1h, 2010 4. Device Descriptio… | 2008 |
| * | K103322 | Evercross 0.035 Otw Pta Dilation CatheterSummary page 1…redicate Devices Device Trade Name EverCrossTM .035" OTW PTA Dilatation Catheter 510(k) Number K082579, K103322 510(k) Clearance Date November 20, 2008, December 6 1h, 2010 4. Device Description… | 2010 |
What descends from it? (5)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 11 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 4 of the 15 ancestors have a recall of any class.
- Of its descendants, K151141 (Nipro Medical Corporation, 2016) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K082579.
How does its category compare?
All LIT devicesLIT Catheter, Angioplasty, Peripheral, Transluminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 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/K110319 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110319: Evercross 0.035 Otw Pta Dilatation Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110319
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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