510(k) Report

510(k) · Cleared

Cleared

ASAHI Corsair Armet

K152249510(k) TraditionalCleared Mar 4, 2016207-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 Mar 4, 2016 as substantially equivalent to K151103 (Asahi Intecc Co., Ltd., 2015) after a 207-day review. Its family tree reaches back 8 generations to 2000. 3 later devices descend from it.

Decided
Mar 4, 2016
Review
207 days
Class
Class II
Product code
DQY
Recalls
None
Predicates
1

Its longest line of descent runs back 8 generations to K001992 (2000). 15 ancestors in all, the oldest K945904 (1995). 3 later devices descend from it, 1 citing it directly.

  1. Root · 8 generations backK001992 Ilt 0.014 Catheter, Model C114NL2Intra Luminal Therapeutics, Inc. · 2000
  2. 7 generations backK012169 Ilt Support Catheter .014, Model C114LW1; Ilt Support Catheter…Intra Luminal Therapeutics, Inc. · 2001
  3. 6 generations backK030984 Safe Cross Angled Support 0.14, Safe Cross Straight Support Catheter…Intra Luminal Therapeutics, Inc. · 2003
  4. 5 generations backK032660 Xtrak Support CatheterXtrak Medical, Inc. · 2003
  5. 4 generations backK051772 Asahi Tornus Support CatheterAsahi Intecc Co., Ltd. · 2005
  6. 3 generations backK062885 Stride MicrocatheterAsahi Intecc Co., Ltd. · 2007
  7. 2 generations backK083127 Asahi Corsair MicrocatheterAsahi Intecc Co., Ltd. · 2009
  8. 1 generation backK151103 ASAHI Corsair MicrocatheterAsahi Intecc Co., Ltd. · 2015
  9. This deviceK152249 ASAHI Corsair ArmetAsahi Intecc Co., Ltd. · 2016
  10. Descendant · cites it directly · 2 of its ownK161362 ASAHI Corsair ArmetAsahi Intecc Co., Ltd. · 2016
  11. Descendant · 2 generations on · 0 of its ownK202252 ASAHI Corsair Armet 18 Microcatheter (Model: CSAR060-18N), ASAHI…Asahi Intecc Co., Ltd. · 2020
  12. Descendant · 2 generations on · 0 of its ownK192782 ASAHI CROSSWALK Peripheral Support CatheterAsahi Intecc Co., Ltd. · 2019

Most influential descendants

Showing 3 of 3 · See all
  • K161362ASAHI Corsair ArmetAsahi Intecc Co., Ltd. · 2016 · cites it directly2descendants
  • K202252ASAHI Corsair Armet 18 Microcatheter (Model: CSAR060-18N), ASAHI Corsair Armet 18…Asahi Intecc Co., Ltd. · 2020 · 2 generations on0descendants
  • K192782ASAHI CROSSWALK Peripheral Support CatheterAsahi Intecc Co., Ltd. · 2019 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−8K001992Ilt 0.014 Catheter, Model C114NL2Intra Luminal Therapeutics, Inc.2000—
−7K012169Ilt Support Catheter .014, Model C114LW1; Ilt Support Catheter Advancing…Intra Luminal Therapeutics, Inc.2001—
−6K030984Safe Cross Angled Support 0.14, Safe Cross Straight Support Catheter 0.14…Intra Luminal Therapeutics, Inc.2003—
−5K032660Xtrak Support CatheterXtrak Medical, Inc.2003—
−4K051772Asahi Tornus Support CatheterAsahi Intecc Co., Ltd.2005—
−3K062885Stride MicrocatheterAsahi Intecc Co., Ltd.2007—
−2K083127Asahi Corsair MicrocatheterAsahi Intecc Co., Ltd.2009—
−1K151103ASAHI Corsair MicrocatheterAsahi Intecc Co., Ltd.2015—
0 (this device)K152249ASAHI Corsair ArmetAsahi Intecc Co., Ltd.2016—
+1K161362ASAHI Corsair ArmetAsahi Intecc Co., Ltd.2016—
+2K202252ASAHI Corsair Armet 18 Microcatheter (Model: CSAR060-18N), ASAHI Corsair Armet…Asahi Intecc Co., Ltd.2020—
+2K192782ASAHI CROSSWALK Peripheral Support CatheterAsahi Intecc Co., Ltd.2019—

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
201610
201910
202010
FIG. 1 — Lineage of K152249, 2000–2020Source: 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
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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
*K151103ASAHI Corsair Microcatheter
Summary page 5
…er PRODUCT CODE DQY- Catheter, Percutaneous PREDICATE DEVICES: Primary Predicates: ASAHI Corsair Microcatheter (K151103) Reference Devices: ASAHI Fubuki 043 (K141981)…
Asahi Intecc Co., Ltd.2015—
†K141981Asahi Fubuki 043 / Asahi FubukiAsahi Intecc Co., Ltd.2015—
†K051772Asahi Tornus Support CatheterAsahi Intecc Co., Ltd.2005—
†K022762Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000, AG143000, AG141002…Jomed, Inc.2002—

Also cleared against K151103: 4 other devices →

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
K161362ASAHI Corsair ArmetAsahi Intecc Co., Ltd.20162

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 16 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
  • None of the 15 ancestors has a recall.
  • Of its descendants, K161362 (Asahi Intecc Co., Ltd., 2016) has gone furthest, with 2 descendants of its own.
  • 4 other devices also cite its predicate K151103.

How does its category compare?

All DQY devices

DQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 Corsair Armet is intended to provide support to facilitate the placement of guide wires in the peripheral vasculature, and can be used to exchange one guide wire for another.

The ASAHI Corsair Armet is also intended to assist in the delivery of contrast media into the peripheral vasculature.

This device should not be used in coronary vasculature or neuro vasculature.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K152249: ASAHI Corsair Armet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K152249

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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