BARD UTRAVERSE SMALL VESSEL PTA BALLOON DILATATION CATHETER— 510(k) K010169

Substantially Equivalent

C.R. Bard, Inc.

FDA 510(k) clearance K010169 for BARD UTRAVERSE SMALL VESSEL PTA BALLOON DILATATION CATHETER, Substantially Equivalent on 2001-02-13. Applicant: C.R. Bard, Inc..

Clearance details

Applicant: C.R. Bard, Inc.
Product code: Code DQY
Advisory panel: Cardiovascular
Date received: 2001-01-18
Decision date: 2001-02-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Covington, GA, US

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Adverse events under product code DQY

product code DQY

Death: 464
Injury: 4,489
Malfunction: 13,721
Other: 2
Total: 18,676

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.