BARD ISOFLOW BLOOD PUMP— 510(k) K971421

Substantially Equivalent

C.R. Bard, Inc.

FDA 510(k) clearance K971421 for BARD ISOFLOW BLOOD PUMP, Substantially Equivalent on 1998-05-14. Applicant: C.R. Bard, Inc..

Clearance details

Applicant: C.R. Bard, Inc.
Product code: Code DWA
Advisory panel: Cardiovascular
Date received: 1997-04-16
Decision date: 1998-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Haverhill, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DWA

product code DWA

Death: 15
Malfunction: 1,654
Total: 1,669

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.