510(k) Report

510(k) · Cleared

Cleared

Asahi Zenyteex Guiding Catheter

K091188510(k) TraditionalCleared Feb 26, 2010309-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 Feb 26, 2010 as substantially equivalent to K023402 (Medtronic Vascular, 2002) and 4 other predicates after a 309-day review. Its family tree reaches back 4 generations to 1998. 1 later device descends from it.

Decided
Feb 26, 2010
Review
309 days
Class
Class II
Product code
DQY
Recalls
None
Predicates
5

Its longest line of descent runs back 4 generations to K981198 (1998). 10 ancestors in all, the oldest K953987 (1995). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2006: 1 other ancestor2002: 1 other ancestor1997: 1 other ancestor2001: 2 other ancestors1995: 1 other ancestor2013: 1 descendant clearedK981198 · Medtronic Zuma Guiding Catheter · Medtronics Interventional Vascular · 1998 · recalled×3: 3 generations cleared close together, K021256 (2002), K022764 (2002), K023402 (2002) 1995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 2 other ancestors3 generations back: 1 other ancestor 1 generation forward: 1 descendant K023402 · 8F Launcher Guide Catheter · Medtronic Vascular · 2002 · recalledK022764 · 7F Launcher Guide Catheter · Medtronic Vascular · 2002 · recalledK021256 · Z3 Guide Catheter · Medtronic Vascular · 2002 · recalledK981198 · Medtronic Zuma Guiding Catheter · Medtronics Interventional Vascular · 1998 · recalled0
  1. Root · 4 generations backK981198 Medtronic Zuma Guiding CatheterMedtronics Interventional Vascular · 1998 · Recalled
  2. 3 generations backK021256 Z3 Guide CatheterMedtronic Vascular · 2002 · Recalled
  3. 2 generations backK022764 7F Launcher Guide CatheterMedtronic Vascular · 2002 · Recalled
  4. 1 generation backK023402 8F Launcher Guide CatheterMedtronic Vascular · 2002 · Recalled
  5. This deviceK091188 Asahi Zenyteex Guiding CatheterAsahi Intecc Co., Ltd. · 2010
  6. Descendant · cites it directly · 0 of its ownK132556 Sheathless Eaucath Coronary Guide CatheterAsahi Intecc Co., Ltd. · 2013

Most influential descendants

Showing 1 of 1 · See all
  • K132556Sheathless Eaucath Coronary Guide CatheterAsahi Intecc Co., Ltd. · 2013 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K981198Medtronic Zuma Guiding CatheterMedtronics Interventional Vascular199825
−3K021256Z3 Guide CatheterMedtronic Vascular200252
−2K0227647F Launcher Guide CatheterMedtronic Vascular200213
−1K0234028F Launcher Guide CatheterMedtronic Vascular200218
0 (this device)K091188Asahi Zenyteex Guiding CatheterAsahi Intecc Co., Ltd.2010—
+1K132556Sheathless Eaucath Coronary Guide CatheterAsahi Intecc Co., Ltd.2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
199710
200120
200210
200610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
FIG. 1 — Lineage of K091188, 1998–2013Source: 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? (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
*K0234028F Launcher Guide Catheter
Summary page 1
…ATION NAME: Catheter, Percutaneous DEVICE Class 2 per 21 CFR §870.1250 CLASSIFICATION: PRODUCT CODE DQY PREDICATE DEVICE: K023402 & K022764 - Medltronic Launcher Guide Catheter K972484 - ACS Viking Guiding Catheter…
Medtronic Vascular200218
*K0227647F Launcher Guide Catheter
Summary page 1
…: Catheter, Percutaneous DEVICE Class 2 per 21 CFR §870.1250 CLASSIFICATION: PRODUCT CODE DQY PREDICATE DEVICE: K023402 & K022764 - Medltronic Launcher Guide Catheter K972484 - ACS Viking Guiding Catheter K06 1601…
Medtronic Vascular200213
*K972484Acs Viking Guiding Catheter
Summary page 1
…ss 2 per 21 CFR §870.1250 CLASSIFICATION: PRODUCT CODE DQY PREDICATE DEVICE: K023402 & K022764 - Medltronic Launcher Guide Catheter K972484 - ACS Viking Guiding Catheter K06 1601 - Precious Guide Catheter K020028 - Mach 1 G…
Guidant Corp.19972
*K061601Asahi Precious Guide Catheter
Summary page 1
…DQY PREDICATE DEVICE: K023402 & K022764 - Medltronic Launcher Guide Catheter K972484 - ACS Viking Guiding Catheter K06 1601 - Precious Guide Catheter K020028 - Mach 1 Guide Catheter DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKE…
Asahi Intecc Co., Ltd.2006—
*K0200286F MACH1/34356-XXX; 5F MACH1/35845-XXX; 7F MACH1/34357-XXX; 8F MACH1/34358-XXX
Summary page 1
…nic Launcher Guide Catheter K972484 - ACS Viking Guiding Catheter K06 1601 - Precious Guide Catheter K020028 - Mach 1 Guide Catheter DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION: The ASAHI ZenyteEX Guiding Catheter is i…
Boston Scientific200211

Also cleared against K023402: 5 other devices →

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K132556Sheathless Eaucath Coronary Guide CatheterAsahi Intecc Co., Ltd.20130

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 12 years and passes through 3 companies; a new generation was cleared every 3.8 years on median.
  • 8 of the 10 ancestors have a recall of any class.
  • Of its descendants, K132556 (Asahi Intecc Co., Ltd., 2013) has gone furthest, with 0 descendants of its own.
  • 5 other devices also cite its predicate K023402.

How does its category compare?

All DQY devices

DQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?

ASAHI ZenyteEX Guiding Catheter is intended for use in coronary or peripheral vascular applications and is designed to provide a pathway through which medical instruments, such as balloon catheters, guide wires or other therapeutic devices may be introduced. This device is not intended for use in the cerebral vasculature.

Indications for use as stated in the FDA summary.

Also cleared against K023402

5 other devices cite the same predicate.

  • K141529Alviguide Blue+ Interventional Cardiology Guiding CatheterAlvimedica Tibbi Urunler Sanayi VE Dis Ticaret A.S · 2014
  • K132556Sheathless Eaucath Coronary Guide CatheterAsahi Intecc Co., Ltd. · 2013
  • K103386Medtronic Vascular - Hub Material Modification to the 5F and 8F Launcher (R) Guide CathetersMedtronic, Inc. · 20111 recall
  • K0604188F Sherpa NX Guide CatheterMedtronic Vascular · 2006
  • K030671Medtronioc 7F Launcher Biopsy Guide Catheter, Model LA7RVBB, Medtronic 8F Launcher Biopsy Catheter, Model…Medtronic Vascular · 2003

More from Asahi Intecc Co., Ltd.

84 FDA decisions under this applicant name. See the company

  • K254178SAYA 86 Radial Access Guide CatheterAsahi Intecc Co., Ltd. · 2026
  • K252011CHIKAI Nexus petitAsahi Intecc Co., Ltd. · 2026
  • K251560FUBUKI XF-R Neurovascular Long SheathAsahi Intecc Co., Ltd. · 2025
  • K251240Branchor X Balloon Guide CatheterAsahi Intecc Co., Ltd. · 2025
  • K243383CHIKAI Nexus 014Asahi Intecc Co., Ltd. · 2025

Recent decisions in DQY

The DQY category page

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https://510kreport.com/device/K091188 · printed Nov 6, 2026

Cite this page

510(k) Report. “K091188: Asahi Zenyteex Guiding Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091188

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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