Presto Inflation Device— 510(k) K143522

Substantially Equivalent

C.R. Bard, Inc.

FDA 510(k) clearance K143522 for Presto Inflation Device, Substantially Equivalent on 2015-01-12. Applicant: C.R. Bard, Inc..

Clearance details

Applicant: C.R. Bard, Inc.
Product code: Code MAV
Advisory panel: Cardiovascular
Date received: 2014-12-12
Decision date: 2015-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tempe, AZ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MAV

product code MAV

Malfunction: 1,433
Total: 1,433

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.