VENOUS RESERVOIR BAG MODEL NO. BMR-800 W/HEPARIN— 510(k) K896414

Name: FDA 510(k) clearance K896414
Creator: U.S. Food and Drug Administration
Published: 1990-01-31

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K896414 for VENOUS RESERVOIR BAG MODEL NO. BMR-800 W/HEPARIN, Substantially Equivalent on 1990-01-31. Applicant: Baxter Healthcare Corp. Device class: 2.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code DTN
Device class: Class 2
Regulation: 21 CFR 870.4400
Advisory panel: Cardiovascular
Date received: 1989-11-08
Decision date: 1990-01-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DTN

product code DTN

Death: 3
Total: 3

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.