FDA 510(k)

CARD 43 CARDIOTOMY RESERVOIR WITH PHOSPHORYLCHOLINE COATING

K-Number: K061527 · 2006-06-27

Decision Date2006-06-27

Product CodeDTN

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

CARD 43 CARDIOTOMY RESERVOIR WITH PHOSPHORYLCHOLINE COATING is the device name listed in this FDA 510(k) record. The listed applicant is Sorin Group Italia S.R.L.. It received FDA 510(k) clearance on 2006-06-27 under 510(k) number K061527. 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 CARD 43 CARDIOTOMY RESERVOIR WITH PHOSPHORYLCHOLINE COATING?

CARD 43 CARDIOTOMY RESERVOIR WITH PHOSPHORYLCHOLINE COATING is a medical device that received FDA 510(k) clearance on 2006-06-27. The listed applicant is Sorin Group Italia S.R.L.. The 510(k) number is K061527.

When did CARD 43 CARDIOTOMY RESERVOIR WITH PHOSPHORYLCHOLINE COATING receive FDA 510(k) clearance?

CARD 43 CARDIOTOMY RESERVOIR WITH PHOSPHORYLCHOLINE COATING received FDA 510(k) clearance on 2006-06-27, under 510(k) number K061527.

Who is the listed applicant for CARD 43 CARDIOTOMY RESERVOIR WITH PHOSPHORYLCHOLINE COATING?

The FDA 510(k) record lists Sorin Group Italia S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARD 43 CARDIOTOMY RESERVOIR WITH PHOSPHORYLCHOLINE COATING?

The FDA product code for CARD 43 CARDIOTOMY RESERVOIR WITH PHOSPHORYLCHOLINE COATING is DTN.

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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.