510(k) Report

510(k) · Cleared

Cleared

Sheathless Eaucath Coronary Guide Catheter

K132556510(k) TraditionalCleared Oct 24, 201371-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 Oct 24, 2013 as substantially equivalent to K021256 (Medtronic Vascular, 2002) and 6 other predicates after a 71-day review. Its family tree reaches back 5 generations to 1992.

Decided
Oct 24, 2013
Review
71 days
Class
Class II
Product code
DQY
Recalls
None
Predicates
7

Its longest line of descent runs back 5 generations to K921310 (1992). 24 ancestors in all, the oldest K863137 (1986). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2010: 1 other ancestor2005: 1 other ancestor2002: 4 other ancestors1997: 1 other ancestor2006: 1 other ancestor2001: 3 other ancestors1998: 3 other ancestors1995: 1 other ancestor1993: 2 other ancestors1992: 1 other ancestor1986: 1 other ancestorK921310 · Cordis 6 French Paragon Angiographic Catheter · Cordis Corp. · 1992K960975 · 1-4F Infiniti Angiographic Catheter · Cordis Corp. · 1996 · recalledK992051 · Radifocus Optitorque · Terumo Medical Corp. · 1999K082736 · Radifocus Optitorque Angiographic Catheter · Terumo Medical Corp. · 2008K092372 · Heartrail Iii Guiding Catheter · Terumo Corp. · 20091985199019952000200520102015
Other ancestors, by generation 1 generation back: 6 other ancestors2 generations back: 7 other ancestors3 generations back: 3 other ancestors4 generations back: 2 other ancestors5 generations back: 1 other ancestor K092372 · Heartrail Iii Guiding Catheter · Terumo Corp. · 2009K082736 · Radifocus Optitorque Angiographic Catheter · Terumo Medical Corp. · 2008K992051 · Radifocus Optitorque · Terumo Medical Corp. · 1999K960975 · 1-4F Infiniti Angiographic Catheter · Cordis Corp. · 1996 · recalledK921310 · Cordis 6 French Paragon Angiographic Catheter · Cordis Corp. · 1992−50
  1. Root · 5 generations backK921310 Cordis 6 French Paragon Angiographic CatheterCordis Corp. · 1992
  2. 4 generations backK960975 1-4F Infiniti Angiographic CatheterCordis Corp. · 1996 · Recalled
  3. 3 generations backK992051 Radifocus OptitorqueTerumo Medical Corp. · 1999
  4. 2 generations backK082736 Radifocus Optitorque Angiographic CatheterTerumo Medical Corp. · 2008
  5. 1 generation backK092372 Heartrail Iii Guiding CatheterTerumo Corp. · 2009
  6. This deviceK132556 Sheathless Eaucath Coronary Guide CatheterAsahi Intecc Co., Ltd. · 2013
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K921310Cordis 6 French Paragon Angiographic CatheterCordis Corp.1992—
−4K9609751-4F Infiniti Angiographic CatheterCordis Corp.19961
−3K992051Radifocus OptitorqueTerumo Medical Corp.1999—
−2K082736Radifocus Optitorque Angiographic CatheterTerumo Medical Corp.2008—
−1K092372Heartrail Iii Guiding CatheterTerumo Corp.2009—
0 (this device)K132556Sheathless Eaucath Coronary Guide CatheterAsahi Intecc Co., Ltd.2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198610
199210
199320
199510
199710
199830
200130
200240
200510
200610
201010
FIG. 1 — Lineage of K132556, 1992–2013Source: 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? (7)

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
*K021256Z3 Guide Catheter
Summary page 1
…Class 2 per 21 CFR §870.1250 CLASSIFICATION: CLASSIFICATION Catheter, Percutaneous NAME: PRODUCT CODE OQY PREDICATE K021256 6F Launcher Guide Catheter (Medtronic Vascular) DEVICES: K022764 7F Launcher Guide Catheter (Medtroni…
Medtronic Vascular200252
*K0227647F Launcher Guide Catheter
Summary page 1
…Catheter, Percutaneous NAME: PRODUCT CODE OQY PREDICATE K021256 6F Launcher Guide Catheter (Medtronic Vascular) DEVICES: K022764 7F Launcher Guide Catheter (Medtronic Vascular) K023402 8F Launcher Guide Catheter (Medtroni…
Medtronic Vascular200213
*K0234028F Launcher Guide Catheter
Summary page 1
…256 6F Launcher Guide Catheter (Medtronic Vascular) DEVICES: K022764 7F Launcher Guide Catheter (Medtronic Vascular) K023402 8F Launcher Guide Catheter (Medtronic Vascular) K972484 ACS Viking Catheter (Guidant Corp.)…
Medtronic Vascular200218
*K972484Acs Viking Guiding Catheter
Summary page 1
…764 7F Launcher Guide Catheter (Medtronic Vascular) K023402 8F Launcher Guide Catheter (Medtronic Vascular) K972484 ACS Viking Catheter (Guidant Corp.) K091 188 ASAHI ZenyteEX Guiding Catheter (ASAHI Inteco…
Guidant Corp.19972
*K091188Asahi Zenyteex Guiding Catheter
Summary page 1
…K023402 8F Launcher Guide Catheter (Medtronic Vascular) K972484 ACS Viking Catheter (Guidant Corp.) K091 188 ASAHI ZenyteEX Guiding Catheter (ASAHI Inteco Co., Ltd. K092…
Asahi Intecc Co., Ltd.2010—
*K092372Heartrail Iii Guiding Catheter
Summary page 1
…ant Corp.) K091 188 ASAHI ZenyteEX Guiding Catheter (ASAHI Inteco Co., Ltd. K092372 Heartrail Ill Guiding Catheter (Terumo Medical Corp.) K051601 Pinnacle Destination (Terumo M…
Terumo Corp.2009—
*K051601Pinnacle Destination Peripheral Guiding Sheath
Summary page 1
…co Co., Ltd. K092372 Heartrail Ill Guiding Catheter (Terumo Medical Corp.) K051601 Pinnacle Destination (Terumo Medical Corp.) DATE PREPARED: July 25, 2013 Asahi Intecc Co., Ltd…
Terumo Medical Corp.2005—

Also cleared against K021256: 6 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 21 years and passes through 4 companies; a new generation was cleared every 3.5 years on median.
  • 13 of the 24 ancestors have a recall of any class.
  • 6 other devices also cite its predicate K021256.

How does its category compare?

All DQY devices

DQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 SheathLess Eaucath Coronary Guide Catheter is intended to provide a pathway through which therapeutic and diagnostic devices are introduced. The guide catheter is intended to be used in the coronary vascular system.

Indications for use as stated in the FDA summary.

Also cleared against K021256

6 other devices cite the same predicate.

  • K141529Alviguide Blue+ Interventional Cardiology Guiding CatheterAlvimedica Tibbi Urunler Sanayi VE Dis Ticaret A.S · 2014
  • K1326735F & 6F Launcher Guide Catheter, 5F Sherpa Active NX Guide Catheter, 6F Z4 Guiding CatheterMedtronic, Inc. · 2013191 Class I recalls
  • K120585Convey Guiding CatheterPendracare International, B.V. · 2012
  • K0424896F Z4 Guide CatheterMedtronic Vascular · 2004191 Class I recalls
  • K0307795F Medtronic Launcher Guide CatheterMedtronic Vascular · 20037 recalls
  • K0227647F Launcher Guide CatheterMedtronic Vascular · 200213 recalls

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/K132556 · printed Nov 6, 2026

Cite this page

510(k) Report. “K132556: Sheathless Eaucath Coronary Guide Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132556

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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