FDA 510(k)

BCD ADVANCED BLOOD CARIOPLEGIA SYSTEMS

K-Number: K925369 · 1993-03-26

ApplicantSorin Biomedica, Fiat, USA, Inc.

Decision Date1993-03-26

Product CodeDTR

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

BCD ADVANCED BLOOD CARIOPLEGIA SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Sorin Biomedica, Fiat, USA, Inc.. It received FDA 510(k) clearance on 1993-03-26 under 510(k) number K925369. 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 BCD ADVANCED BLOOD CARIOPLEGIA SYSTEMS?

BCD ADVANCED BLOOD CARIOPLEGIA SYSTEMS is a medical device that received FDA 510(k) clearance on 1993-03-26. The listed applicant is Sorin Biomedica, Fiat, USA, Inc.. The 510(k) number is K925369.

When did BCD ADVANCED BLOOD CARIOPLEGIA SYSTEMS receive FDA 510(k) clearance?

BCD ADVANCED BLOOD CARIOPLEGIA SYSTEMS received FDA 510(k) clearance on 1993-03-26, under 510(k) number K925369.

Who is the listed applicant for BCD ADVANCED BLOOD CARIOPLEGIA SYSTEMS?

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

What is the FDA product code for BCD ADVANCED BLOOD CARIOPLEGIA SYSTEMS?

The FDA product code for BCD ADVANCED BLOOD CARIOPLEGIA SYSTEMS is DTR.

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Related Devices (Code: 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.