510(k) Report

510(k) · Cleared

Recalled · 2010

Modification to: Nanocross 0.14 Otw Pta Dilatation Catheter, Models AB14W020210090, AB14W020210150

K090849510(k) SpecialCleared May 1, 200932-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. · DQY Catheter, Percutaneous

Cleared on May 1, 2009 as substantially equivalent to K082854 (Ev3, Inc., 2008) after a 32-day review. Its family tree reaches back 1 generation to 2008. 25 later devices descend from it. It has been recalled once.

Decided
May 1, 2009
Review
32 days
Class
Class II
Product code
DQY
Recalls
1
Predicates
1

Its longest line of descent runs back 1 generation to K082854 (2008). 25 later devices descend from it, 9 citing it directly.

Descendants, by year cleared 2011: 3 descendants cleared2013: 4 descendants cleared2009: 1 descendant cleared2012: 3 descendants cleared2010: 2 descendants cleared2016: 4 descendants cleared2014: 1 descendant cleared2015: 2 descendants cleared2021: 1 descendant cleared2020: 1 descendant cleared2024: 1 descendant cleared2025: 1 descendant cleared2026: 1 descendant clearedK082854 · Nanocorss .014 Otw Pta Dilatation Catheter · Ev3, Inc. · 2008 · recalled20052010201520202025
Descendants, by generation 1 generation forward: 9 descendants2 generations forward: 8 descendants3 generations forward: 6 descendants4 generations forward: 2 descendants K082854 · Nanocorss .014 Otw Pta Dilatation Catheter · Ev3, Inc. · 2008 · recalled0
  1. Root · 1 generation backK082854 Nanocorss .014 Otw Pta Dilatation CatheterEv3, Inc. · 2008 · Recalled
  2. This deviceK090849 Modification to: Nanocross 0.14 Otw Pta Dilatation Catheter, Models…Ev3, Inc. · 2009
  3. Descendant · cites it directly · 14 of its ownK093286 Powercross .018 Otw Pta Dilation CatheterEv3, Inc. · 2009 · Recalled
  4. Descendant · cites it directly · 8 of its ownK123544 Rapidcross Pta Rapid Exchange, Balloon Dilatation CatheterEv3, Inc. · 2013
  5. Descendant · cites it directly · 8 of its ownK101062 Glider Pta Balloon CatheterTrireme Medical, Inc. · 2010
  6. Descendant · 2 generations on · 7 of its ownK130911 Rapidcross Pta Rapid Exchange Balloon Dilatation CatheterEv3, Inc. · 2013
  7. Descendant · cites it directly · 6 of its ownK132777 Nanocross Elite .14 Over-the-Wire Pta, Balloon Dilation CatheterEv3, Inc. · 2013

Showing 5 of 25 descendants. See all descendants

Descendants cleared per year

2009: 12010: 22011: 32012: 32013: 42014: 12015: 22016: 42020: 12021: 12024: 12025: 12026: 1
2009high 4 (2013) · low 0 (2017)2026

Most influential descendants

Showing 5 of 25 · See all
  • K093286Powercross .018 Otw Pta Dilation CatheterEv3, Inc. · 2009 · cites it directly14descendants
  • K123544Rapidcross Pta Rapid Exchange, Balloon Dilatation CatheterEv3, Inc. · 2013 · cites it directly8descendants
  • 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 · cites it directly6descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K082854Nanocorss .014 Otw Pta Dilatation CatheterEv3, Inc.20081
0 (this device)K090849Modification to: Nanocross 0.14 Otw Pta Dilatation Catheter, Models…Ev3, Inc.2009—
+1K093286Powercross .018 Otw Pta Dilation CatheterEv3, Inc.20092
+1K123544Rapidcross Pta Rapid Exchange, Balloon Dilatation CatheterEv3, Inc.2013—
+1K101062Glider Pta Balloon CatheterTrireme Medical, Inc.2010—
+2K130911Rapidcross Pta Rapid Exchange Balloon Dilatation CatheterEv3, Inc.2013—
+1K132777Nanocross Elite .14 Over-the-Wire Pta, Balloon Dilation CatheterEv3, Inc.2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201020
201130
201230
201340
201410
201520
201640
202010
202110
202410
202510
202610
FIG. 1 — Lineage of K090849, 2008–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

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. #1 K234115 APRO 55 Catheterscore 17.5 · 6 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (1)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K082854Nanocorss .014 Otw Pta Dilatation Catheter
Summary page 1
…ous Classification Panel Cardiovascular Predicate Device NanoCross .014" OTw PTA Dilatation Catheter (K082854) Intended use =h =aoMs774715T o…
Ev3, Inc.20081

Also cleared against K082854: 2 other devices →

What descends from it? (25)

See all 25

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

NumberDeviceApplicantDecidedDescendants
K093286Powercross .018 Otw Pta Dilation CatheterEv3, Inc.200914
K123544Rapidcross Pta Rapid Exchange, Balloon Dilatation CatheterEv3, Inc.20138
K101062Glider Pta Balloon CatheterTrireme Medical, Inc.20108
K132777Nanocross Elite .14 Over-the-Wire Pta, Balloon Dilation CatheterEv3, Inc.20136
K103534Gliderxtreme Pta Balloon Catheter (CB) (Over the Wire) 0.014 / 0.018 Guide WireTrireme Medical, Inc.20116
K111738Chocolate Pta Balloon Catheter (Over the Wire) Guide Wire (0.014 and 0.018)Trireme Medical, Inc.20115
K120677Chocolate Pta Ballon Catheter (Over the Wire) Guide Wire (0.014)Trireme Medical, Inc.20124
K094019Glider Pta Balloon CatheterTrireme Medical, Inc.20104
K121402Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire Chocolate Pta Balloon…Trireme Medical, Inc.20123

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

Recalls of this device

DateClassRecallRoot causeReason
Nov 12, 2010Not classifiedZ-0789-2011Process controlev3 has determined that specific lots of the NanoCross .014 OTW PTA Dilatation catheters may crack or break during use. Cracking or breaking of the catheter shaft can result in the inability to inflate or deflate the balloon, and can…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has a recall.
  • Of its descendants, K093286 (Ev3, Inc., 2009) has gone furthest, with 14 descendants of its own.
  • 2 other devices also cite its predicate K082854.

How does its category compare?

All DQY devices

DQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · DQY

21in 2025

2007: 162008: 312009: 372010: 222011: 362012: 302013: 322014: 192015: 272016: 222017: 262018: 252019: 302020: 202021: 182022: 182023: 182024: 162025: 212026 (partial year): 11
2007high 37 (2009) · low 16 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQY

115in 2025

2007: 85 days median2008: 66 days median2009: 73 days median2010: 74 days median2011: 71 days median2012: 87 days median2013: 92 days median2014: 127 days median2015: 118 days median2016: 117 days median2017: 113 days median2018: 106 days median2019: 111 days median2020: 120 days median2021: 81 days median2022: 74 days median2023: 114 days median2024: 87 days median2025: 115 days median2026 (partial year): 30 days median
2007high 127 (2014) · low 66 (2008)2026

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

Recalls per year · DQY

1in 2025

2007: 62008: 122009: 172010: 322011: 62012: 22013: 36, 1 Class I2014: 32015: 32016: 22, 7 Class I2017: 82018: 22019: 12020: 22021: 22023: 172024: 12025: 1, 1 Class I2026 (partial year): 2, 1 Class I
2007high 36 (2013) · low 0 (2022)2026

Class I (10 since 2007) Class II/III not classified

Adverse event reports per year · DQY

3,056in 2025

2007: 3132008: 4962009: 8192010: 1,2932011: 1,2112012: 1,1912013: 1,3522014: 1,4972015: 2,3372016: 2,2522017: 2,4892018: 2,8552019: 2,9022020: 2,8892021: 3,0062022: 2,6432023: 3,0492024: 3,1902025: 3,056
2007high 3,190 (2024) · low 313 (2007)2025

MAUDE reports naming product code DQY, 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
200716856313
2008316612496
2009377317819
20102274321,293
2011367161,211
2012308721,191
2013329236 (1)1,352
20141912731,497
20152711832,337
20162211722 (7)2,252
20172611382,489
20182510622,855
20193011112,902
20202012022,889
2021188123,006
2022187402,643
202318114173,049
2024168713,190
2025211151 (1)3,056
202611302 (1)—

What is it indicated for?

The NanoCross 0.014" 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.

Indications for use as stated in the FDA summary.

Also cleared against K082854

2 other devices cite the same predicate.

  • K132777Nanocross Elite .14 Over-the-Wire Pta, Balloon Dilation CatheterEv3, Inc. · 2013
  • K123544Rapidcross Pta Rapid Exchange, Balloon Dilatation CatheterEv3, Inc. · 2013

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 DQY

The DQY category page

  • K262817CrossFAST Integrated Microcatheter Advanced Delivery SystemVantis Vascular, Inc. · 2026
  • K260559NHanceITIMDS Operation B.V. · 2026
  • K262392APRO 35 Swift CatheterAlembic, LLC · 2026
  • K261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLC · 2026
  • K262240SSPC NXT Delivery CatheterCenterPoint Systems, LLC · 2026

https://510kreport.com/device/K090849 · printed Nov 6, 2026

Cite this page

510(k) Report. “K090849: Modification to: Nanocross 0.14 Otw Pta Dilatation Catheter, Models AB14W020210090, AB14W020210150.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090849

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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