510(k) Report

510(k) · Cleared

Cleared

Xtrak Support Catheter

K032660510(k) TraditionalCleared Oct 29, 200362-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

Xtrak Medical, Inc. · DQY Catheter, Percutaneous

Cleared on Oct 29, 2003 as substantially equivalent to K030984 (Intra Luminal Therapeutics, Inc., 2003) after a 62-day review. Its family tree reaches back 3 generations to 2000. 1 of the 124 devices in its family, counting itself, has a Class I recall. 120 later devices descend from it.

Decided
Oct 29, 2003
Review
62 days
Class
Class II
Product code
DQY
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K001992 (2000). 120 later devices descend from it, 1 citing it directly. 1 of the 124 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2005: 1 descendant cleared2008: 2 descendants cleared2009: 7 descendants cleared2007: 2 descendants cleared2006: 1 descendant cleared2012: 17 descendants cleared2014: 6 descendants cleared, 1 with a Class I recall12010: 5 descendants cleared2011: 5 descendants cleared2017: 8 descendants cleared2021: 8 descendants cleared2018: 6 descendants cleared2016: 12 descendants cleared2015: 9 descendants cleared2022: 6 descendants cleared2019: 4 descendants cleared2020: 8 descendants cleared2026: 2 descendants cleared2023: 5 descendants cleared2013: 2 descendants cleared2024: 2 descendants cleared2025: 2 descendants clearedK001992 · Ilt 0.014 Catheter, Model C114NL2 · Intra Luminal Therapeutics, Inc. · 2000K012169 · Ilt Support Catheter .014, Model C114LW1; Ilt Support Catheter Advancing Mechanism, Model A11AM1 · Intra Luminal Therapeutics, Inc. · 2001K030984 · Safe Cross Angled Support 0.14, Safe Cross Straight Support Catheter 0.14, Safe Cross Angled Support Catheter, Safe Crot · Intra Luminal Therapeutics, Inc. · 2003200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 10 descendants3 generations forward: 21 descendants4 generations forward: 26 descendants5 generations forward: 23 descendants6 generations forward: 16 descendants7 generations forward: 9 descendants, 1 with a Class I recall18 generations forward: 6 descendants9 generations forward: 5 descendants10 generations forward: 2 descendants11 generations forward: 1 descendant K030984 · Safe Cross Angled Support 0.14, Safe Cross Straight Support Catheter 0.14, Safe Cross Angled Support Catheter, Safe Crot · Intra Luminal Therapeutics, Inc. · 2003K012169 · Ilt Support Catheter .014, Model C114LW1; Ilt Support Catheter Advancing Mechanism, Model A11AM1 · Intra Luminal Therapeutics, Inc. · 2001K001992 · Ilt 0.014 Catheter, Model C114NL2 · Intra Luminal Therapeutics, Inc. · 20000+5+10
  1. Root · 3 generations backK001992 Ilt 0.014 Catheter, Model C114NL2Intra Luminal Therapeutics, Inc. · 2000
  2. 2 generations backK012169 Ilt Support Catheter .014, Model C114LW1; Ilt Support Catheter…Intra Luminal Therapeutics, Inc. · 2001
  3. 1 generation backK030984 Safe Cross Angled Support 0.14, Safe Cross Straight Support Catheter…Intra Luminal Therapeutics, Inc. · 2003
  4. This deviceK032660 Xtrak Support CatheterXtrak Medical, Inc. · 2003
  5. Descendant · cites it directly · 119 of its ownK051772 Asahi Tornus Support CatheterAsahi Intecc Co., Ltd. · 2005
  6. Descendant · 2 generations on · 44 of its ownK070372 Gopher 2F Support Catheter, Model 5600 and Gopher 3F Support…Vascular Solutions, Inc. · 2007
  7. Descendant · 2 generations on · 34 of its ownK062885 Stride MicrocatheterAsahi Intecc Co., Ltd. · 2007
  8. Descendant · 2 generations on · 33 of its ownK083127 Asahi Corsair MicrocatheterAsahi Intecc Co., Ltd. · 2009
  9. Descendant · 2 generations on · 22 of its ownK060745 Asahi Tornus Support Catheter with Torque Device AccessoryAsahi Intecc Co., Ltd. · 2006

Showing 5 of 120 descendants. See all descendants

Descendants cleared per year

2005: 12006: 12007: 22008: 22009: 72010: 52011: 52012: 172013: 22014: 62015: 92016: 122017: 82018: 62019: 42020: 82021: 82022: 62023: 52024: 22025: 22026: 2
2005high 17 (2012) · low 1 (2005)2026

Class I recalls in this family

  • K141547 Wingman Extendable Tip Support Catheter7 generations on · 2014

Most influential descendants

Showing 5 of 120 · See all
  • K051772Asahi Tornus Support CatheterAsahi Intecc Co., Ltd. · 2005 · cites it directly119descendants
  • K070372Gopher 2F Support Catheter, Model 5600 and Gopher 3F Support Catheter, Model 5610Vascular Solutions, Inc. · 2007 · 2 generations on44descendants
  • K062885Stride MicrocatheterAsahi Intecc Co., Ltd. · 2007 · 2 generations on34descendants
  • K083127Asahi Corsair MicrocatheterAsahi Intecc Co., Ltd. · 2009 · 2 generations on33descendants
  • K060745Asahi Tornus Support Catheter with Torque Device AccessoryAsahi Intecc Co., Ltd. · 2006 · 2 generations on22descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K001992Ilt 0.014 Catheter, Model C114NL2Intra Luminal Therapeutics, Inc.2000—
−2K012169Ilt Support Catheter .014, Model C114LW1; Ilt Support Catheter Advancing…Intra Luminal Therapeutics, Inc.2001—
−1K030984Safe Cross Angled Support 0.14, Safe Cross Straight Support Catheter 0.14…Intra Luminal Therapeutics, Inc.2003—
0 (this device)K032660Xtrak Support CatheterXtrak Medical, Inc.2003—
+1K051772Asahi Tornus Support CatheterAsahi Intecc Co., Ltd.2005—
+2K070372Gopher 2F Support Catheter, Model 5600 and Gopher 3F Support Catheter, Model…Vascular Solutions, Inc.2007—
+2K062885Stride MicrocatheterAsahi Intecc Co., Ltd.2007—
+2K083127Asahi Corsair MicrocatheterAsahi Intecc Co., Ltd.2009—
+2K060745Asahi Tornus Support Catheter with Torque Device AccessoryAsahi Intecc Co., Ltd.2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200610
200720
200820
200970
201050
201150
2012170
201320
201461
201590
2016120
201780
201860
201940
202080
202180
202260
202350
202420
202520
202620
FIG. 1 — Lineage of K032660, 2000–2026Source: 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.

1 device in this family has a Class I recall. 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
*K030984Safe Cross Angled Support 0.14, Safe Cross Straight Support Catheter 0.14, Safe Cross…
Summary page 1
…893-7708 Contact: Gary Boseck, Ph.D. Identification of Predicate or Legally Marketed Devices: ILT Safe Cross Support Catheter (K030984) manufactured by Intraluminal Therapeutics, Inc. Intended Use: The Xtrak Support catheter is intended to be used in conjunction…
Intra Luminal Therapeutics, Inc.2003—

Also cleared against K030984: 1 other device →

What descends from it? (120)

See all 120

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K051772Asahi Tornus Support CatheterAsahi Intecc Co., Ltd.2005119

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K141547Wingman Extendable Tip Support CatheterReflow Medical · 2014 · 7 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 11 months on median.
  • None of the 3 ancestors has a recall.
  • Of its descendants, K051772 (Asahi Intecc Co., Ltd., 2005) has gone furthest, with 119 descendants of its own.
  • 1 other device also cites its predicate K030984.

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 Xtrak Support Catheter is intended to be used in conjunction with a steerable guidewire in order to access discreet regions of the vasculature.

Indications for use as stated in the FDA summary.

Also cleared against K030984

1 other device cites the same predicate.

  • K031417Ilt Safe Cross 0.035 Support Catheter, Model C135SN1Intra Luminal Therapeutics, Inc. · 2003

More from Xtrak Medical, Inc.

3 FDA decisions under this applicant name. See the company

  • K021641XTD Thrombectomy Catheter, XX CMXtrak Medical, Inc. · 20021 recall
  • K013473XTD Thrombectomy Catheter, XX CM, Model# CT000500X; XTD Control Console, Model # CT0006001; XTD Collection…Xtrak Medical, Inc. · 2002

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/K032660 · printed Nov 6, 2026

Cite this page

510(k) Report. “K032660: Xtrak Support Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032660

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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