FDA 510(k)

HYPOTHERMIC MYCARDIAL PROTECTION DEV

K-Number: K832417 · 1983-10-20

Decision Date1983-10-20

Product CodeDTR

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

HYPOTHERMIC MYCARDIAL PROTECTION DEV is the device name listed in this FDA 510(k) record. The listed applicant is 3M Health Care, Sarns. It received FDA 510(k) clearance on 1983-10-20 under 510(k) number K832417. The device is classified under product code DTR. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYPOTHERMIC MYCARDIAL PROTECTION DEV?

HYPOTHERMIC MYCARDIAL PROTECTION DEV is a medical device that received FDA 510(k) clearance on 1983-10-20. The listed applicant is 3M Health Care, Sarns. The 510(k) number is K832417.

When did HYPOTHERMIC MYCARDIAL PROTECTION DEV receive FDA 510(k) clearance?

HYPOTHERMIC MYCARDIAL PROTECTION DEV received FDA 510(k) clearance on 1983-10-20, under 510(k) number K832417.

Who is the listed applicant for HYPOTHERMIC MYCARDIAL PROTECTION DEV?

The FDA 510(k) record lists 3M Health Care, Sarns as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HYPOTHERMIC MYCARDIAL PROTECTION DEV?

The FDA product code for HYPOTHERMIC MYCARDIAL PROTECTION DEV is DTR.

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Official Source

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