FDA 510(k)

VENOUS RESERVOIR BAG MODEL NO. BMR-800 W/HEPARIN

K-Number: K896414 · 1990-01-31

Decision Date1990-01-31

Product CodeDTN

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

VENOUS RESERVOIR BAG MODEL NO. BMR-800 W/HEPARIN is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 1990-01-31 under 510(k) number K896414. 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 VENOUS RESERVOIR BAG MODEL NO. BMR-800 W/HEPARIN?

VENOUS RESERVOIR BAG MODEL NO. BMR-800 W/HEPARIN is a medical device that received FDA 510(k) clearance on 1990-01-31. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K896414.

When did VENOUS RESERVOIR BAG MODEL NO. BMR-800 W/HEPARIN receive FDA 510(k) clearance?

VENOUS RESERVOIR BAG MODEL NO. BMR-800 W/HEPARIN received FDA 510(k) clearance on 1990-01-31, under 510(k) number K896414.

Who is the listed applicant for VENOUS RESERVOIR BAG MODEL NO. BMR-800 W/HEPARIN?

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

What is the FDA product code for VENOUS RESERVOIR BAG MODEL NO. BMR-800 W/HEPARIN?

The FDA product code for VENOUS RESERVOIR BAG MODEL NO. BMR-800 W/HEPARIN is 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.