510(k) Report

510(k) · Cleared

Cleared

Stride Microcatheter

K062885510(k) TraditionalCleared Jun 13, 2007260-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

Asahi Intecc Co., Ltd. · DQY Catheter, Percutaneous

Cleared on Jun 13, 2007 as substantially equivalent to K050599 (Boston Scientific Corp, 2005) and 2 other predicates after a 260-day review. Its family tree reaches back 5 generations to 2000. 34 later devices descend from it.

Decided
Jun 13, 2007
Review
260 days
Class
Class II
Product code
DQY
Recalls
None
Predicates
3

Its longest line of descent runs back 5 generations to K001992 (2000). 12 ancestors in all, the oldest K945904 (1995). 34 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2005: 1 other ancestor1997: 2 other ancestors2000: 1 other ancestor1995: 2 other ancestors1996: 1 other ancestor2009: 1 descendant cleared2014: 2 descendants cleared2012: 1 descendant cleared2017: 3 descendants cleared2018: 4 descendants cleared2016: 4 descendants cleared2015: 3 descendants cleared2022: 3 descendants cleared2021: 1 descendant cleared2020: 6 descendants cleared2024: 2 descendants cleared2019: 1 descendant cleared2023: 1 descendant 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. · 2003K032660 · Xtrak Support Catheter · Xtrak Medical, Inc. · 2003K051772 · Asahi Tornus Support Catheter · Asahi Intecc Co., Ltd. · 20051995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 4 other ancestors3 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 6 descendants3 generations forward: 12 descendants4 generations forward: 6 descendants5 generations forward: 6 descendants6 generations forward: 2 descendants7 generations forward: 1 descendant K051772 · Asahi Tornus Support Catheter · Asahi Intecc Co., Ltd. · 2005K032660 · Xtrak Support Catheter · Xtrak Medical, Inc. · 2003K030984 · 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. · 2000−50+5
  1. Root · 5 generations backK001992 Ilt 0.014 Catheter, Model C114NL2Intra Luminal Therapeutics, Inc. · 2000
  2. 4 generations backK012169 Ilt Support Catheter .014, Model C114LW1; Ilt Support Catheter…Intra Luminal Therapeutics, Inc. · 2001
  3. 3 generations backK030984 Safe Cross Angled Support 0.14, Safe Cross Straight Support Catheter…Intra Luminal Therapeutics, Inc. · 2003
  4. 2 generations backK032660 Xtrak Support CatheterXtrak Medical, Inc. · 2003
  5. 1 generation backK051772 Asahi Tornus Support CatheterAsahi Intecc Co., Ltd. · 2005
  6. This deviceK062885 Stride MicrocatheterAsahi Intecc Co., Ltd. · 2007
  7. Descendant · cites it directly · 33 of its ownK083127 Asahi Corsair MicrocatheterAsahi Intecc Co., Ltd. · 2009
  8. Descendant · 2 generations on · 20 of its ownK151103 ASAHI Corsair MicrocatheterAsahi Intecc Co., Ltd. · 2015
  9. Descendant · 2 generations on · 11 of its ownK161126 ASAHI Corsair ProAsahi Intecc Co., Ltd. · 2016
  10. Descendant · 2 generations on · 9 of its ownK112035 Valet Micro CatheterVolcano Corporation · 2012
  11. Descendant · 2 generations on · 7 of its ownK171933 ASAHI PTCA Guide Wires, ASAHI Corsair Microcatheter, ASAHI Corsair…Asahi Intecc Co., Ltd. · 2018

Showing 5 of 34 descendants. See all descendants

Descendants cleared per year

2009: 12012: 12014: 22015: 32016: 42017: 32018: 42019: 12020: 62021: 12022: 32023: 12024: 22025: 2
2009high 6 (2020) · low 0 (2010)2026

Most influential descendants

Showing 5 of 34 · See all
  • K083127Asahi Corsair MicrocatheterAsahi Intecc Co., Ltd. · 2009 · cites it directly33descendants
  • K151103ASAHI Corsair MicrocatheterAsahi Intecc Co., Ltd. · 2015 · 2 generations on20descendants
  • K161126ASAHI Corsair ProAsahi Intecc Co., Ltd. · 2016 · 2 generations on11descendants
  • K112035Valet Micro CatheterVolcano Corporation · 2012 · 2 generations on9descendants
  • K171933ASAHI PTCA Guide Wires, ASAHI Corsair Microcatheter, ASAHI Corsair Pro MicrocatheterAsahi Intecc Co., Ltd. · 2018 · 2 generations on7descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K001992Ilt 0.014 Catheter, Model C114NL2Intra Luminal Therapeutics, Inc.2000—
−4K012169Ilt Support Catheter .014, Model C114LW1; Ilt Support Catheter Advancing…Intra Luminal Therapeutics, Inc.2001—
−3K030984Safe Cross Angled Support 0.14, Safe Cross Straight Support Catheter 0.14…Intra Luminal Therapeutics, Inc.2003—
−2K032660Xtrak Support CatheterXtrak Medical, Inc.2003—
−1K051772Asahi Tornus Support CatheterAsahi Intecc Co., Ltd.2005—
0 (this device)K062885Stride MicrocatheterAsahi Intecc Co., Ltd.2007—
+1K083127Asahi Corsair MicrocatheterAsahi Intecc Co., Ltd.2009—
+2K151103ASAHI Corsair MicrocatheterAsahi Intecc Co., Ltd.2015—
+2K161126ASAHI Corsair ProAsahi Intecc Co., Ltd.2016—
+2K112035Valet Micro CatheterVolcano Corporation2012—
+2K171933ASAHI PTCA Guide Wires, ASAHI Corsair Microcatheter, ASAHI Corsair Pro…Asahi Intecc Co., Ltd.2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199520
199610
199720
200010
200510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201210
201420
201530
201640
201730
201840
201910
202060
202110
202230
202310
202420
202520
FIG. 1 — Lineage of K062885, 2000–2025Source: 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 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? (3)

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
*K050599Tracker Excel -14 Pre-Shaped Microcatheter
Summary page 1
…Percutaneous Catheter DEVICE Class 2 per 21 CFR §870.1250 CLASSIFICATION: PRODUCT CODE DQY PREDICATE DEVICE: Boston Scientific Tracker Excel - 14 (K050599) Cordis Transit/Rapid Transit/Spedster/Prowler (K97251 8) ASHAI Tomus Support Catheter (K0517…
Boston Scientific Corp2005—
*K972518Transit/Rapidtransit/Speedster/Prowler Infusion Catheter
Summary page 1
…0 CLASSIFICATION: PRODUCT CODE DQY PREDICATE DEVICE: Boston Scientific Tracker Excel - 14 (K050599) Cordis Transit/Rapid Transit/Spedster/Prowler (K97251 8) ASHAI Tomus Support Catheter (K051772) DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION: Asahi Stri…
Cordis Neurovascular, Inc.1997—
*K051772Asahi Tornus Support Catheter
Summary page 1
…Boston Scientific Tracker Excel - 14 (K050599) Cordis Transit/Rapid Transit/Spedster/Prowler (K97251 8) ASHAI Tomus Support Catheter (K051772) DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION: Asahi Stride Microcatheter consists of catheter (soft tip tube and…
Asahi Intecc Co., Ltd.2005—

Also cleared against K050599: 1 other device →

What descends from it? (34)

See all 34

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

NumberDeviceApplicantDecidedDescendants
K083127Asahi Corsair MicrocatheterAsahi Intecc Co., Ltd.200933

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?

  • The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
  • None of the 12 ancestors has a recall.
  • Of its descendants, K083127 (Asahi Intecc Co., Ltd., 2009) has gone furthest, with 33 descendants of its own.
  • 1 other device also cites its predicate K050599.

How does its category compare?

All DQY devices

DQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 ASAHI Stride Microcatheter is intended to provide support to facilitate the placement of guide wires in the coronary and peripheral vasculature and can be used to exchange one guidewire for another. The Asahi Stride Microcatheter is also intended to assist in the delivery of diagnostic agents, such as contrast media and therapeutic agents, such as occlusion coils into the coronary and peripheral vasculature.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K062885: Stride Microcatheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062885

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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