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FDA 510(k)

SHEATHLESS EAUCATH CORONARY GUIDE CATHETER

K-Number: K132556 · 2013-10-24

ApplicantAsahi Intecc Co., Ltd.
Decision Date2013-10-24
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SHEATHLESS EAUCATH CORONARY GUIDE CATHETER 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 2013-10-24 under 510(k) number K132556. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHEATHLESS EAUCATH CORONARY GUIDE CATHETER?

SHEATHLESS EAUCATH CORONARY GUIDE CATHETER is a medical device that received FDA 510(k) clearance on 2013-10-24. The listed applicant is Asahi Intecc Co., Ltd.. The 510(k) number is K132556.

When did SHEATHLESS EAUCATH CORONARY GUIDE CATHETER receive FDA 510(k) clearance?

SHEATHLESS EAUCATH CORONARY GUIDE CATHETER received FDA 510(k) clearance on 2013-10-24, under 510(k) number K132556.

Who is the listed applicant for SHEATHLESS EAUCATH CORONARY GUIDE CATHETER?

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 SHEATHLESS EAUCATH CORONARY GUIDE CATHETER?

The FDA product code for SHEATHLESS EAUCATH CORONARY GUIDE CATHETER is DQY.

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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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