VENOUS RESERVOIR BAG MODEL NO. BMR-250(TM)— 510(k) K913692

Substantially Equivalent

Bentley Laboratories, Inc.

FDA 510(k) clearance K913692 for VENOUS RESERVOIR BAG MODEL NO. BMR-250(TM), Substantially Equivalent on 1991-11-15. Applicant: Bentley Laboratories, Inc..

Clearance details

Applicant: Bentley Laboratories, Inc.
Product code: Code DTN
Advisory panel: Cardiovascular
Date received: 1991-08-19
Decision date: 1991-11-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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.