510(k) Report

510(k) · Cleared

Cleared

Vascutrak Pta Dilation Catheter

K063657510(k) TraditionalCleared Dec 12, 20064-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

Ymed, Inc. · PNO Catheter, Percutaneous, Cutting/Scoring

Cleared on Dec 12, 2006 as substantially equivalent to K042624 (Invatec Innovative Technologies, S.R.L., 2005) and 3 other predicates after a 4-day review. Its family tree reaches back 1 generation to 1997. 52 later devices descend from it.

Decided
Dec 12, 2006
Review
4 days
Class
Class II
Product code
PNO
Recalls
None
Predicates
4

Its longest line of descent runs back 1 generation to K971010 (1997). 4 ancestors in all. 52 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2005: 1 other ancestor2000: 2 other ancestors2007: 1 descendant cleared2012: 4 descendants cleared2010: 3 descendants cleared2008: 1 descendant cleared2011: 4 descendants cleared2020: 4 descendants cleared2016: 3 descendants cleared2013: 2 descendants cleared2015: 2 descendants cleared2014: 1 descendant cleared2022: 4 descendants cleared2019: 2 descendants cleared2017: 3 descendants cleared2025: 3 descendants cleared2024: 6 descendants cleared2021: 3 descendants cleared2026: 4 descendants cleared2018: 2 descendants clearedK971010 · Peripheral Transluminal Angioplasty Catheters · Cordis Corp. · 19971995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 3 descendants2 generations forward: 6 descendants3 generations forward: 11 descendants4 generations forward: 9 descendants5 generations forward: 9 descendants6 generations forward: 6 descendants7 generations forward: 3 descendants8 generations forward: 4 descendants9 generations forward: 1 descendant K971010 · Peripheral Transluminal Angioplasty Catheters · Cordis Corp. · 19970+5
  1. Root · 1 generation backK971010 Peripheral Transluminal Angioplasty CathetersCordis Corp. · 1997
  2. This deviceK063657 Vascutrak Pta Dilation CatheterYmed, Inc. · 2006
  3. Descendant · cites it directly · 48 of its ownK073025 Vascutrak II Pta Dilatation CatheterThermopeutix, Inc. Dba Ymed, Inc. · 2007
  4. Descendant · 2 generations on · 47 of its ownK082343 Vascutrak 2, Models: V14 and V18Ymed, Inc. · 2008
  5. Descendant · 3 generations on · 36 of its ownK103459 Vascutrak Pta Dilatation CatheterC.R. Bard, Inc. · 2010
  6. Descendant · cites it directly · 32 of its ownK100303 Angiosculpt Pta Scoring Balloon Catheter Model 2039-Xxyy, 2076-Xxyy…Angioscore, Inc. · 2010
  7. Descendant · 2 generations on · 30 of its ownK110767 Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc. · 2011

Showing 5 of 52 descendants. See all descendants

Descendants cleared per year

2007: 12008: 12010: 32011: 42012: 42013: 22014: 12015: 22016: 32017: 32018: 22019: 22020: 42021: 32022: 42024: 62025: 32026: 4
2007high 6 (2024) · low 0 (2009)2026

Most influential descendants

Showing 5 of 52 · See all
  • K073025Vascutrak II Pta Dilatation CatheterThermopeutix, Inc. Dba Ymed, Inc. · 2007 · cites it directly48descendants
  • K082343Vascutrak 2, Models: V14 and V18Ymed, Inc. · 2008 · 2 generations on47descendants
  • K103459Vascutrak Pta Dilatation CatheterC.R. Bard, Inc. · 2010 · 3 generations on36descendants
  • K100303Angiosculpt Pta Scoring Balloon Catheter Model 2039-Xxyy, 2076-Xxyy, 2092-Xxyy, 2105-XxyyAngioscore, Inc. · 2010 · cites it directly32descendants
  • K110767Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc. · 2011 · 2 generations on30descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K971010Peripheral Transluminal Angioplasty CathetersCordis Corp.1997—
0 (this device)K063657Vascutrak Pta Dilation CatheterYmed, Inc.2006—
+1K073025Vascutrak II Pta Dilatation CatheterThermopeutix, Inc. Dba Ymed, Inc.2007—
+2K082343Vascutrak 2, Models: V14 and V18Ymed, Inc.2008—
+3K103459Vascutrak Pta Dilatation CatheterC.R. Bard, Inc.2010—
+1K100303Angiosculpt Pta Scoring Balloon Catheter Model 2039-Xxyy, 2076-Xxyy…Angioscore, Inc.2010—
+2K110767Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc.2011—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200020
200510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200810
201030
201140
201240
201320
201410
201520
201630
201730
201820
201920
202040
202130
202240
202460
202530
202640
FIG. 1 — Lineage of K063657, 1997–2026Source: 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), 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 PNO? 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 PNO device

  1. #1 K261778 JADE SCORE PTA Scoring Balloon Dilatation…score 14.1 · 8 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K042624Amphirion Deep 0.014 Otw Pta Balloon Catheter
Summary page 4
…any currently marketed balloon dilatalion catheters used for peripheral angioplasty procedures; these predicate catheters are: 1) Invatec Amphirion™ Deep PTA Catheter (K042624) 2) Cordis SAVVY® PTA Dilatation Catheter (K971010) 3) Guidant VIATRAC® 14 Peripheral Dilatation Catheter (KO00101) 4) Boston Sc…
Invatec Innovative Technologies, S.R.L.20051
*K971010Peripheral Transluminal Angioplasty Catheters
Summary page 4
…used for peripheral angioplasty procedures; these predicate catheters are: 1) Invatec Amphirion™ Deep PTA Catheter (K042624) 2) Cordis SAVVY® PTA Dilatation Catheter (K971010) 3) Guidant VIATRAC® 14 Peripheral Dilatation Catheter (KO00101) 4) Boston Scientific Gazelle™ Balloon Dilatation Catheter (K001…
Cordis Corp.1997—
*K000101RX Viatrac 14 Peripheral Dilatation CatheterGuidant Corp.2000—
*K001134Gazelle Balloon Dilatation Catheter
Summary page 4
…rdis SAVVY® PTA Dilatation Catheter (K971010) 3) Guidant VIATRAC® 14 Peripheral Dilatation Catheter (KO00101) 4) Boston Scientific Gazelle™ Balloon Dilatation Catheter (K001134) Page 10 of 128 ThermopeutiX, Inc. (YMed) 510(k) Premarket Notificaiion November 16, 2006 Ko63657 Indications f…
Boston Scientific Corp2000—

Also cleared against K042624: 4 other devices →

What descends from it? (52)

See all 52

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

NumberDeviceApplicantDecidedDescendants
K073025Vascutrak II Pta Dilatation CatheterThermopeutix, Inc. Dba Ymed, Inc.200748
K100303Angiosculpt Pta Scoring Balloon Catheter Model 2039-Xxyy, 2076-Xxyy, 2092-Xxyy, 2105-XxyyAngioscore, Inc.201032
K113103Splitwire Percutaneous Transluminal Angioplasty Scoring DeviceRex Medical20125

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?

  • 1 of the 4 ancestors has a recall of any class.
  • Of its descendants, K073025 (Thermopeutix, Inc. Dba Ymed, Inc., 2007) has gone furthest, with 48 descendants of its own.
  • 4 other devices also cite its predicate K042624.

How does its category compare?

All PNO devices

PNO Catheter, Percutaneous, Cutting/Scoring: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · PNO

2in 2025

2007: 32008: 42009: 12010: 32011: 22012: 12013: 12014: 12015: 42016: 12017: 32019: 12020: 42021: 12022: 22024: 42025: 22026 (partial year): 3
2007high 4 (2008) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PNO

246in 2024

2007: 61 days median2008: 28 days median2010: 23 days median2015: 84 days median2017: 74 days median2020: 94 days median2024: 246 days median2026 (partial year): 110 days median
2007high 246 (2024) · low 23 (2010)2026

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

Recalls per year · PNO

No recall names PNO since 2007.

Adverse event reports per year · PNO

511in 2025

2016: 92017: 262018: 552019: 812020: 1212021: 902022: 752023: 3042024: 5372025: 511
2007high 537 (2024) · low 0 (2007)2025

MAUDE reports naming product code PNO, 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
200736100
200842800
20091—00
201032300
20112—00
20121—00
20131—00
20141—00
201548400
20161—09
2017374026
20180—055
20191—081
20204940121
20211—090
20222—075
20230—0304
202442460537
20252—0511
202631100—

What is it indicated for?

The VascuTraK™ PTA Dilatation Catheter is intended for dilatation of stenoses in the peripheral arteries including the iliac, femoral, popliteal, ilio-femoral, infrapopliteal and 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 K042624

4 other devices cite the same predicate.

  • K142954PTA 14 Balloon Dilatation Catheter OTWTexasmedical Technologies, Inc. · 2015
  • K102645Willow/Elm Pta Balloon Dilatation CatheterCreagh Medical, Ltd. · 2010
  • K083919Amphirion Deep 0.014 Otw Pta Balloon CatheterInvatec Innovative Technologies, S.R.L. · 20091 recall
  • K050276Diver C.E. CatheterInvatec Innovative Technologies, S.R.L. · 20051 recall

More from Ymed, Inc.

2 FDA decisions under this applicant name. See the company

  • K082343Vascutrak 2, Models: V14 and V18Ymed, Inc. · 2008

Recent decisions in PNO

The PNO category page

  • K260686Zylox PanFlex Percutaneous Transluminal Angioplasty Scoring CatheterZylox Medtech Co., Ltd. · 2026
  • K261778JADE SCORE PTA Scoring Balloon Dilatation CatheterOrbusNeich Medical (Shenzhen) Co., Ltd. · 2026
  • K260012UltraScore™ Focused Force PTA BalloonBard Peripheral Vascular, Inc. · 2026
  • K243944Aperta NSE PTA Balloon Dilatation CatheterGoodman Co., Ltd. · 2025
  • K242254D·Kutting™ LL Peripheral Scoring Balloon Dilatation CatheterDk Medical Technology Co., Ltd. · 2025

https://510kreport.com/device/K063657 · printed Nov 5, 2026

Cite this page

510(k) Report. “K063657: Vascutrak Pta Dilation Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K063657

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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