FDA 510(k)

STRYKER CONSTAVAC BLOOD CONSERVATION SYSTEM II (CBCII)

K-Number: K970714 · 1997-12-16

Decision Date1997-12-16

Product CodeCAC

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

STRYKER CONSTAVAC BLOOD CONSERVATION SYSTEM II (CBCII) is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Instruments. It received FDA 510(k) clearance on 1997-12-16 under 510(k) number K970714. The device is classified under product code CAC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STRYKER CONSTAVAC BLOOD CONSERVATION SYSTEM II (CBCII)?

STRYKER CONSTAVAC BLOOD CONSERVATION SYSTEM II (CBCII) is a medical device that received FDA 510(k) clearance on 1997-12-16. The listed applicant is Stryker Instruments. The 510(k) number is K970714.

When did STRYKER CONSTAVAC BLOOD CONSERVATION SYSTEM II (CBCII) receive FDA 510(k) clearance?

STRYKER CONSTAVAC BLOOD CONSERVATION SYSTEM II (CBCII) received FDA 510(k) clearance on 1997-12-16, under 510(k) number K970714.

Who is the listed applicant for STRYKER CONSTAVAC BLOOD CONSERVATION SYSTEM II (CBCII)?

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

What is the FDA product code for STRYKER CONSTAVAC BLOOD CONSERVATION SYSTEM II (CBCII)?

The FDA product code for STRYKER CONSTAVAC BLOOD CONSERVATION SYSTEM II (CBCII) is CAC.

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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.