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FDA 510(k)

QUEST MPS PERFUSION ASSISTED DIRECT CORONARY ARTERY BYPASS (PADCAB)

K-Number: K994274 · 2000-05-31

ApplicantQuest Medical, Inc.
Decision Date2000-05-31
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

QUEST MPS PERFUSION ASSISTED DIRECT CORONARY ARTERY BYPASS (PADCAB) is the device name listed in this FDA 510(k) record. The listed applicant is Quest Medical, Inc.. It received FDA 510(k) clearance on 2000-05-31 under 510(k) number K994274. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUEST MPS PERFUSION ASSISTED DIRECT CORONARY ARTERY BYPASS (PADCAB)?

QUEST MPS PERFUSION ASSISTED DIRECT CORONARY ARTERY BYPASS (PADCAB) is a medical device that received FDA 510(k) clearance on 2000-05-31. The listed applicant is Quest Medical, Inc.. The 510(k) number is K994274.

When did QUEST MPS PERFUSION ASSISTED DIRECT CORONARY ARTERY BYPASS (PADCAB) receive FDA 510(k) clearance?

QUEST MPS PERFUSION ASSISTED DIRECT CORONARY ARTERY BYPASS (PADCAB) received FDA 510(k) clearance on 2000-05-31, under 510(k) number K994274.

Who is the listed applicant for QUEST MPS PERFUSION ASSISTED DIRECT CORONARY ARTERY BYPASS (PADCAB)?

The FDA 510(k) record lists Quest Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QUEST MPS PERFUSION ASSISTED DIRECT CORONARY ARTERY BYPASS (PADCAB)?

The FDA product code for QUEST MPS PERFUSION ASSISTED DIRECT CORONARY ARTERY BYPASS (PADCAB) is FRN.

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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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