FDA 510(k)

MYOCARD PROTECT SYST W/BLOOD CARDIO HEAT EXC/MODIF

K-Number: K914742 · 1991-12-04

Decision Date1991-12-04

Product CodeDTR

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MYOCARD PROTECT SYST W/BLOOD CARDIO HEAT EXC/MODIF is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 1991-12-04 under 510(k) number K914742. 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 MYOCARD PROTECT SYST W/BLOOD CARDIO HEAT EXC/MODIF?

MYOCARD PROTECT SYST W/BLOOD CARDIO HEAT EXC/MODIF is a medical device that received FDA 510(k) clearance on 1991-12-04. The listed applicant is Medtronic Vascular. The 510(k) number is K914742.

When did MYOCARD PROTECT SYST W/BLOOD CARDIO HEAT EXC/MODIF receive FDA 510(k) clearance?

MYOCARD PROTECT SYST W/BLOOD CARDIO HEAT EXC/MODIF received FDA 510(k) clearance on 1991-12-04, under 510(k) number K914742.

Who is the listed applicant for MYOCARD PROTECT SYST W/BLOOD CARDIO HEAT EXC/MODIF?

The FDA 510(k) record lists Medtronic Vascular as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MYOCARD PROTECT SYST W/BLOOD CARDIO HEAT EXC/MODIF?

The FDA product code for MYOCARD PROTECT SYST W/BLOOD CARDIO HEAT EXC/MODIF 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.