ASAHI PTCA Guide Wires, ASAHI Corsair Microcatheter, ASAHI Corsair Pro Microcat…

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K171933

Identifiers

510(k) Number: K171933 FDA 510(k)
FDA Product Code: DQX FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 870.1330 FDA 510(k)
Regulation Number: 870.1330 FDA 510(k)
Advisory Committee: Cardiovascular FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

ASAHI PTCA Guide Wires, ASAHI Corsair Microcatheter, ASAHI Corsair Pro Microcat… by Asahi Intecc Co., Ltd. — Class II — MDD, FDA_510K — listed in FDA 510(k)…

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDD	—	Class II	Active
FDA 510(k)	United States	FDA_510K	K171933	Class II	Active

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Asahi Intecc Co., Ltd.

Sources (2)

FDA 510(k) K171933 24 fields · synced Jun 19, 2026
EUDAMED 1 fields · synced May 19, 2026