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FDA 510(k)

ASAHI PTCA CATHETER GUIDE WIRES, MODELS AGH147000 AND AGH147300

K-Number: K032615 · 2003-09-16

ApplicantAsahi Intecc Co., Ltd.
Decision Date2003-09-16
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ASAHI PTCA CATHETER GUIDE WIRES, MODELS AGH147000 AND AGH147300 is the device name listed in this FDA 510(k) record. The listed applicant is Asahi Intecc Co., Ltd.. It received FDA 510(k) clearance on 2003-09-16 under 510(k) number K032615. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASAHI PTCA CATHETER GUIDE WIRES, MODELS AGH147000 AND AGH147300?

ASAHI PTCA CATHETER GUIDE WIRES, MODELS AGH147000 AND AGH147300 is a medical device that received FDA 510(k) clearance on 2003-09-16. The listed applicant is Asahi Intecc Co., Ltd.. The 510(k) number is K032615.

When did ASAHI PTCA CATHETER GUIDE WIRES, MODELS AGH147000 AND AGH147300 receive FDA 510(k) clearance?

ASAHI PTCA CATHETER GUIDE WIRES, MODELS AGH147000 AND AGH147300 received FDA 510(k) clearance on 2003-09-16, under 510(k) number K032615.

Who is the listed applicant for ASAHI PTCA CATHETER GUIDE WIRES, MODELS AGH147000 AND AGH147300?

The FDA 510(k) record lists Asahi Intecc Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ASAHI PTCA CATHETER GUIDE WIRES, MODELS AGH147000 AND AGH147300?

The FDA product code for ASAHI PTCA CATHETER GUIDE WIRES, MODELS AGH147000 AND AGH147300 is DQX.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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