FDA 510(k)

DIDECO FLEXIBLE RESERVOIR -- PRODUCT DESIGNATION 5063

K-Number: K945065 · 1995-05-19

Decision Date1995-05-19

Product CodeDTN

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

DIDECO FLEXIBLE RESERVOIR -- PRODUCT DESIGNATION 5063 is the device name listed in this FDA 510(k) record. The listed applicant is Sorin Biomedical, Inc.. It received FDA 510(k) clearance on 1995-05-19 under 510(k) number K945065. 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 DIDECO FLEXIBLE RESERVOIR -- PRODUCT DESIGNATION 5063?

DIDECO FLEXIBLE RESERVOIR -- PRODUCT DESIGNATION 5063 is a medical device that received FDA 510(k) clearance on 1995-05-19. The listed applicant is Sorin Biomedical, Inc.. The 510(k) number is K945065.

When did DIDECO FLEXIBLE RESERVOIR -- PRODUCT DESIGNATION 5063 receive FDA 510(k) clearance?

DIDECO FLEXIBLE RESERVOIR -- PRODUCT DESIGNATION 5063 received FDA 510(k) clearance on 1995-05-19, under 510(k) number K945065.

Who is the listed applicant for DIDECO FLEXIBLE RESERVOIR -- PRODUCT DESIGNATION 5063?

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

What is the FDA product code for DIDECO FLEXIBLE RESERVOIR -- PRODUCT DESIGNATION 5063?

The FDA product code for DIDECO FLEXIBLE RESERVOIR -- PRODUCT DESIGNATION 5063 is DTN.

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Other records listing Sorin Biomedical, Inc. as applicant

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Related Devices (Code: DTN)

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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.