510(k) Report

510(k) · Cleared

Cleared

Cordis Aviator Peripheral Dilatation Catheter

K013581510(k) SpecialCleared Nov 28, 200130-day reviewClass II21 CFR 870.1250

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Cordis, A Johnson & Johnson Co. · DQY Catheter, Percutaneous

Cleared on Nov 28, 2001 as substantially equivalent to K971448 (Cordis Corp., 1997) and 4 other predicates after a 30-day review. Its family tree reaches back 1 generation to 1997. 65 later devices descend from it.

Decided
Nov 28, 2001
Review
30 days
Class
Class II
Product code
DQY
Recalls
None
Predicates
5

Its longest line of descent runs back 1 generation to K971448 (1997). 5 ancestors in all. 65 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 2 other ancestors2000: 1 other ancestor1998: 1 other ancestor2005: 2 descendants cleared2010: 3 descendants cleared2008: 4 descendants cleared2007: 3 descendants cleared2011: 3 descendants cleared2009: 1 descendant cleared2012: 3 descendants cleared2022: 7 descendants cleared2015: 7 descendants cleared2013: 1 descendant cleared2014: 2 descendants cleared2017: 2 descendants cleared2020: 4 descendants cleared2016: 4 descendants cleared2024: 6 descendants cleared2026: 4 descendants cleared2025: 2 descendants cleared2021: 3 descendants cleared2018: 2 descendants cleared2019: 2 descendants clearedK971448 · Cordis Opta LP Pta Balloon Catheter · Cordis Corp. · 19971995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors 1 generation forward: 4 descendants2 generations forward: 9 descendants3 generations forward: 8 descendants4 generations forward: 12 descendants5 generations forward: 12 descendants6 generations forward: 8 descendants7 generations forward: 6 descendants8 generations forward: 5 descendants9 generations forward: 1 descendant K971448 · Cordis Opta LP Pta Balloon Catheter · Cordis Corp. · 19970+5
  1. Root · 1 generation backK971448 Cordis Opta LP Pta Balloon CatheterCordis Corp. · 1997
  2. This deviceK013581 Cordis Aviator Peripheral Dilatation CatheterCordis, A Johnson & Johnson Co. · 2001
  3. Descendant · cites it directly · 38 of its ownK050629 Angiosculpt Scoring Balloon CatheterAngioscore, Inc. · 2005
  4. Descendant · 2 generations on · 37 of its ownK072225 Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc. · 2007 · Recalled
  5. Descendant · cites it directly · 36 of its ownK080151 Angiosculpt Pta Scoring Balloon Catheter, Models 2076 and 2039Angioscore, Inc. · 2008 · Recalled
  6. Descendant · 2 generations on · 34 of its ownK082059 Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc. · 2008
  7. Descendant · 2 generations on · 34 of its ownK081220 Modification to Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc. · 2008

Showing 5 of 65 descendants. See all descendants

Descendants cleared per year

2005: 22007: 32008: 42009: 12010: 32011: 32012: 32013: 12014: 22015: 72016: 42017: 22018: 22019: 22020: 42021: 32022: 72024: 62025: 22026: 4
2005high 7 (2015) · low 0 (2006)2026

Most influential descendants

Showing 5 of 65 · See all
  • K050629Angiosculpt Scoring Balloon CatheterAngioscore, Inc. · 2005 · cites it directly38descendants
  • K072225Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc. · 2007 · 2 generations on37descendants
  • K080151Angiosculpt Pta Scoring Balloon Catheter, Models 2076 and 2039Angioscore, Inc. · 2008 · cites it directly36descendants
  • K082059Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc. · 2008 · 2 generations on34descendants
  • K081220Modification to Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc. · 2008 · 2 generations on34descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K971448Cordis Opta LP Pta Balloon CatheterCordis Corp.1997—
0 (this device)K013581Cordis Aviator Peripheral Dilatation CatheterCordis, A Johnson & Johnson Co.2001—
+1K050629Angiosculpt Scoring Balloon CatheterAngioscore, Inc.2005—
+2K072225Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc.20075
+1K080151Angiosculpt Pta Scoring Balloon Catheter, Models 2076 and 2039Angioscore, Inc.20085
+2K082059Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc.2008—
+2K081220Modification to Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc.2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810
200010
200120

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200520
200730
200840
200910
201030
201130
201230
201310
201420
201570
201640
201720
201820
201920
202040
202130
202270
202460
202520
202640
FIG. 1 — Lineage of K013581, 1997–2026Source: 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? (5)

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
*K971448Cordis Opta LP Pta Balloon Catheter
Summary page 1
…e Cordis AVIATOR Peripheral Dilatation Catheter are substantially equivalent to those featured among the following predicate devices: Cordis OPTA® LP PTA Catheter (ref. K971448 and K981407), Cordis SLALOM™ 018 PTA Balloon Catheter (ref. K003159); Cordis M3 PTA Dilatation Catheter (ref. K003920); and, G…
Cordis Corp.1997—
*K981407Opta LP Pta Balloon Catheter/Powerflex Plus Pta Balloon Catheter
Summary page 1
…ATOR Peripheral Dilatation Catheter are substantially equivalent to those featured among the following predicate devices: Cordis OPTA® LP PTA Catheter (ref. K971448 and K981407), Cordis SLALOM™ 018 PTA Balloon Catheter (ref. K003159); Cordis M3 PTA Dilatation Catheter (ref. K003920); and, Guidant AVIAT…
Cordis Corp.1998—
*K003159Cordis Slalom Pta Balloon Catheter
Summary page 1
…ivalent to those featured among the following predicate devices: Cordis OPTA® LP PTA Catheter (ref. K971448 and K981407), Cordis SLALOM™ 018 PTA Balloon Catheter (ref. K003159); Cordis M3 PTA Dilatation Catheter (ref. K003920); and, Guidant AVIATOR Peripheral Dilatation Catheter (ref. KO10831). Page 1…
Cordis Corp.2000—
*K003920Cordis M3 Pta Dilatation Catheter
Summary page 1
…cate devices: Cordis OPTA® LP PTA Catheter (ref. K971448 and K981407), Cordis SLALOM™ 018 PTA Balloon Catheter (ref. K003159); Cordis M3 PTA Dilatation Catheter (ref. K003920); and, Guidant AVIATOR Peripheral Dilatation Catheter (ref. KO10831). Page 1 of 3 AVIATOR PTA Dilatation Cathet…
Cordis Corp.2001—
*K010831Aviator Peripheral Dilatation CatheterGuidant Corp.2001—

Also cleared against K971448: 4 other devices →

What descends from it? (65)

See all 65

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

NumberDeviceApplicantDecidedDescendants
K050629Angiosculpt Scoring Balloon CatheterAngioscore, Inc.200538
K080151Angiosculpt Pta Scoring Balloon Catheter, Models 2076 and 2039Angioscore, Inc.200836
K100303Angiosculpt Pta Scoring Balloon Catheter Model 2039-Xxyy, 2076-Xxyy, 2092-Xxyy, 2105-XxyyAngioscore, Inc.201032
K050645Cordis Amiia .014 Pta Balloon CatheterCordis Corp.200525

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?

  • None of the 5 ancestors has a recall.
  • Of its descendants, K050629 (Angioscore, Inc., 2005) has gone furthest, with 38 descendants of its own.
  • 4 other devices also cite its predicate K971448.

How does its category compare?

All DQY devices

DQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years.

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 Cordis AVIATOR Peripheral Dilatation catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra popliteal, renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K971448

4 other devices cite the same predicate.

  • K023463Cvsi Peripheral Balloon Catheter; Cvsi Catheter Inflation UnitCryo Vascular Systems, Inc. · 2003
  • K022061Cvsi Peripheral Balloon Catheter; Cvsi InflaterCryo Vascular Systems, Inc. · 2002
  • K012590Cordis Palmaz Genesis Transhepatic Biliary Stent on Opta Pro .035 Delivery SystemCordis Corp. · 2001
  • K991028Cordis Palmaz Corinthian Transhepatic Biliary Stent and AccessoriesCordis Corp. · 1999

More from Cordis, A Johnson & Johnson Co.

4 FDA decisions under this applicant name. See the company

  • K140286Optease Vena Cava Filter and Optease Retrieval CathteterCordis, A Johnson & Johnson Co. · 2014
  • K012090Cordis Palmaz Genesis Transhepatic Biliary StentCordis, A Johnson & Johnson Co. · 2001
  • K992755Cordis Palmaz Corinthian Transhepatic Biliary Stent and Delivery System, Cordis Crimping Tools, Cordis…Cordis, A Johnson & Johnson Co. · 1999

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/K013581 · printed Nov 6, 2026

Cite this page

510(k) Report. “K013581: Cordis Aviator Peripheral 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/K013581

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 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026