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FDA 510(k)

MYOTHERM (TM) XP CARDIOPLEGIA DELIVERY SYSTEM

K-Number: K971105 · 1997-07-11

ApplicantAvecor Cardiovascular, Inc.
Decision Date1997-07-11
Product CodeDTN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MYOTHERM (TM) XP CARDIOPLEGIA DELIVERY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Avecor Cardiovascular, Inc.. It received FDA 510(k) clearance on 1997-07-11 under 510(k) number K971105. The device is classified under product code DTN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MYOTHERM (TM) XP CARDIOPLEGIA DELIVERY SYSTEM?

MYOTHERM (TM) XP CARDIOPLEGIA DELIVERY SYSTEM is a medical device that received FDA 510(k) clearance on 1997-07-11. The listed applicant is Avecor Cardiovascular, Inc.. The 510(k) number is K971105.

When did MYOTHERM (TM) XP CARDIOPLEGIA DELIVERY SYSTEM receive FDA 510(k) clearance?

MYOTHERM (TM) XP CARDIOPLEGIA DELIVERY SYSTEM received FDA 510(k) clearance on 1997-07-11, under 510(k) number K971105.

Who is the listed applicant for MYOTHERM (TM) XP CARDIOPLEGIA DELIVERY SYSTEM?

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

What is the FDA product code for MYOTHERM (TM) XP CARDIOPLEGIA DELIVERY SYSTEM?

The FDA product code for MYOTHERM (TM) XP CARDIOPLEGIA DELIVERY SYSTEM is DTN.

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Other records listing Avecor Cardiovascular, Inc. as applicant

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Related Devices (Code: DTN)

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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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