510(k) Report

510(k) · Cleared

Recalled · Class II · 2014

Evercross 0.035 Otw Pta Dilation Catheter

K103322510(k) TraditionalCleared Dec 6, 201024-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

Ev3, Inc. · LIT Catheter, Angioplasty, Peripheral, Transluminal

Cleared on Dec 6, 2010 after a 24-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it. It has been recalled once.

Decided
Dec 6, 2010
Review
24 days
Class
Class II
Product code
LIT
Recalls
1
Predicates
0

6 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2014: 1 descendant cleared2011: 2 descendants cleared2016: 1 descendant cleared2019: 2 descendants cleared2010201520202025
  1. This deviceK103322 Evercross 0.035 Otw Pta Dilation CatheterEv3, Inc. · 2010
  2. Descendant · cites it directly · 5 of its ownK110319 Evercross 0.035 Otw Pta Dilatation CatheterEv3, Inc. · 2011
  3. Descendant · 2 generations on · 1 of its ownK151141 Cronus HP - High Pressure Peripheral Balloon CatheterNipro Medical Corporation · 2016
  4. Descendant · 3 generations on · 0 of its ownK190037 Cronus HP PTA Balloon CatheterNipro Medical Corporation · 2019
  5. Descendant · 2 generations on · 0 of its ownK190753 EverCrossTM 0.035 OTW PTA Dilatation CatheterMedtronic, Inc. (Formerly D.B.A. Ev3, Inc. Covidien, LLC.) · 2019
  6. Descendant · cites it directly · 0 of its ownK142654 Fortrex 0.035 OTW PTA Balloon CatheterCovidien, LLC · 2014

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2011: 22014: 12016: 12019: 2
2011high 2 (2011) · low 0 (2012)2026

Most influential descendants

Showing 5 of 6 · See all
  • K110319Evercross 0.035 Otw Pta Dilatation CatheterEv3, Inc. · 2011 · cites it directly5descendants
  • K151141Cronus HP - High Pressure Peripheral Balloon CatheterNipro Medical Corporation · 2016 · 2 generations on1descendant
  • K190037Cronus HP PTA Balloon CatheterNipro Medical Corporation · 2019 · 3 generations on0descendants
  • K190753EverCrossTM 0.035 OTW PTA Dilatation CatheterMedtronic, Inc. (Formerly D.B.A. Ev3, Inc. Covidien, LLC.) · 2019 · 2 generations on0descendants
  • K142654Fortrex 0.035 OTW PTA Balloon CatheterCovidien, LLC · 2014 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K103322Evercross 0.035 Otw Pta Dilation CatheterEv3, Inc.2010—
+1K110319Evercross 0.035 Otw Pta Dilatation CatheterEv3, Inc.2011—
+2K151141Cronus HP - High Pressure Peripheral Balloon CatheterNipro Medical Corporation2016—
+3K190037Cronus HP PTA Balloon CatheterNipro Medical Corporation2019—
+2K190753EverCrossTM 0.035 OTW PTA Dilatation CatheterMedtronic, Inc. (Formerly D.B.A. Ev3, Inc. Covidien, LLC.)2019—
+1K142654Fortrex 0.035 OTW PTA Balloon CatheterCovidien, LLC2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201120
201410
201610
201920
FIG. 1 — Lineage of K103322, 2010–2019Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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. #1 K241040 Amethyst HP PTA OTW 0.035 Catheterscore 13.9 · 9 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K110319Evercross 0.035 Otw Pta Dilatation CatheterEv3, Inc.20115
K142654Fortrex 0.035 OTW PTA Balloon CatheterCovidien, LLC20140

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

Recalls of this device

DateClassRecallRoot causeReason
Apr 9, 2014Class IIZ-1489-2014Labeling Change ControlCovidien 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?

  • Of its descendants, K110319 (Ev3, Inc., 2011) has gone furthest, with 5 descendants of its own.

How does its category compare?

All LIT devices

LIT Catheter, Angioplasty, Peripheral, Transluminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · LIT

3in 2025

2007: 62008: 82009: 72010: 132011: 102012: 192013: 142014: 122015: 192016: 112017: 92018: 62019: 42020: 92021: 42022: 82023: 62024: 62025: 32026 (partial year): 4
2007high 19 (2012) · low 3 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LIT

90in 2025

2007: 64 days median2008: 53 days median2009: 29 days median2010: 78 days median2011: 82 days median2012: 29 days median2013: 79 days median2014: 90 days median2015: 112 days median2016: 116 days median2017: 57 days median2018: 118 days median2019: 40 days median2020: 125 days median2021: 61 days median2022: 122 days median2023: 167 days median2024: 43 days median2025: 90 days median2026 (partial year): 205 days median
2007high 205 (2026) · low 29 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LIT

1in 2025

2009: 22010: 12013: 2, 2 Class I2014: 32016: 12018: 22019: 32021: 12024: 22025: 1
2007high 3 (2014) · low 0 (2007)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · LIT

2,073in 2025

2007: 5772008: 5132009: 6232010: 8092011: 8572012: 1,2772013: 1,2422014: 1,1782015: 1,2792016: 1,5292017: 2,0812018: 2,1882019: 2,4052020: 2,4432021: 2,4922022: 2,1552023: 1,8072024: 1,9132025: 2,073
2007high 2,492 (2021) · low 513 (2008)2025

MAUDE reports naming product code LIT, 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
20076640577
20088530513
20097292623
201013781809
201110820857
2012192901,277
201314792 (2)1,242
2014129031,178
20151911201,279
20161111611,529
201795702,081
2018611822,188
201944032,405
2020912502,443
202146112,492
2022812202,155
2023616701,807
202464321,913
202539012,073
202642050—

More from Ev3, Inc.

35 FDA decisions under this applicant name. See the company

  • K141118Nanocross Eite 0.014 Over-the-Wire Pta Balloon Dilatation CatheterEv3, Inc. · 20141 recall
  • K132777Nanocross Elite .14 Over-the-Wire Pta, Balloon Dilation CatheterEv3, Inc. · 2013
  • K130911Rapidcross Pta Rapid Exchange Balloon Dilatation CatheterEv3, Inc. · 2013
  • K123544Rapidcross Pta Rapid Exchange, Balloon Dilatation CatheterEv3, Inc. · 2013
  • K111723Turbohawk Peripheral Plaque Excision SystemEv3, Inc. · 20111 recall

Recent decisions in LIT

The LIT category page

  • K260416ZYLOX Hippo PTA Balloon Dilatation CatheterZylox Medtech Co., Ltd. · 2026
  • K254212NC PTA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd. · 2026
  • K260304WAVE PTA Balloon CatheterWAVE Medical AG · 2026
  • K252512Armada™ 14 NC PTA CatheterAbbott Medical · 2026
  • K251915Amethyst HP PTA OTW 0.035 CatheterNatec Medical, Ltd. · 2025

https://510kreport.com/device/K103322 · printed Nov 6, 2026

Cite this page

510(k) Report. “K103322: Evercross 0.035 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/K103322

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026