# Asahi Intecc Co., Ltd.

- Location (FDA's records): Seto, JP
- FDA decisions: 84 (2003–2026): 84 510(k) clearances
- Product codes: DQX (47), DQY (19), MOF (10), QJP (6), FGE (1), DQO (1)
- 510(k) review time since 2016: median 133 days, against 134 for FDA's reviews in the same codes and years (18 of 44 faster)
- Predicates its devices cite: 222 (139 its own); citations of its devices by later devices: 185 (139 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Jomed, Inc.: 31 (https://510kreport.com/company/jomed)
- Guidant Corp.: 11 (https://510kreport.com/company/guidant)
- Boston Scientific Corp: 9 (https://510kreport.com/company/boston-scientific)
- Medtronic Vascular: 5 (https://510kreport.com/company/medtronic-vascular)
- Micro Therapeutics, Inc.: 5 (https://510kreport.com/company/micro-therapeutics)
- Cordis Corp.: 4 (https://510kreport.com/company/cordis)
- Terumo Medical Corp.: 2 (https://510kreport.com/company/terumo-medical)
- Terumo Corp.: 1 (https://510kreport.com/company/terumo)

## Firms that cite its devices most
- Filmecc Co., Ltd.: 6 (https://510kreport.com/company/filmecc)
- Vascular Solutions, Inc.: 5 (https://510kreport.com/company/vascular-solutions)
- Asahi Intecc USA, Inc.: 3 (https://510kreport.com/company/asahi-intecc-usa)
- Bridgepoint Medical: 3 (https://510kreport.com/company/bridgepoint-medical)
- St Jude Medical: 2 (https://510kreport.com/company/st-jude-medical)
- Endocross, Ltd.: 2 (https://510kreport.com/company/endocross)
- Tatara Vascular, LLC: 2 (https://510kreport.com/company/tatara-vascular)
- Lake Region Medical: 2 (https://510kreport.com/company/lake-region-medical)

## Its most-cited devices
- K041531: Asahi Ptca Guide Wire Confianza Pro (2004), cited by 12
- K051772: Asahi Tornus Support Catheter (2005), cited by 10
- K052339: Asahi Ptca Guide Wire (2005), cited by 9
- K052022: Asahi Ptca Guide Wire Fielder (2005), cited by 8
- K071721: Asahi Astato 30 Peripheral Guide Wire, Models - PAGH18M071, PAGH18M371 (2007), cited by 7
- K163426: ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire Extension (2017), cited by 7

## Recent decisions
- K254178: SAYA 86 Radial Access Guide Catheter (May 11, 2026)
- K252011: CHIKAI Nexus petit (Feb 2, 2026)
- K251560: FUBUKI XF-R Neurovascular Long Sheath (Jun 20, 2025)
- K251240: Branchor X Balloon Guide Catheter (Jun 20, 2025)
- K243383: CHIKAI Nexus 014 (Apr 21, 2025)
- K243733: SION blue PLUS (Apr 2, 2025)
- K241962: Crossloop (Mar 27, 2025)
- K242597: CROSSLEAD 0.018inch (Mar 5, 2025)

Source page: https://510kreport.com/company/asahi-intecc