BARD 9FR., 40CC. REDIGUARD AND TAPERSEAL INTRA-AORTIC BALLOONS— 510(k) K980850

Substantially Equivalent

C.R. Bard, Inc.

FDA 510(k) clearance K980850 for BARD 9FR., 40CC. REDIGUARD AND TAPERSEAL INTRA-AORTIC BALLOONS, Substantially Equivalent on 1998-06-03. Applicant: C.R. Bard, Inc..

Clearance details

Applicant: C.R. Bard, Inc.
Product code: Code DSP
Advisory panel: Cardiovascular
Date received: 1998-03-05
Decision date: 1998-06-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Haverhill, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DSP

product code DSP

Death: 317
Injury: 566
Malfunction: 36,831
Other: 4
Total: 37,718

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.