TRUE DILATATION BALLOON VALVULOPLASTY CATHETER, 20MM X 4.5 CM, 22MM X 4.5CM, 24 MM X 4.5CM, 26MM X 4.5CM— 510(k) K133569

Name: FDA 510(k) clearance K133569
Creator: U.S. Food and Drug Administration
Published: 2013-12-20

Substantially Equivalent

Bard Peripheral Vascular, Inc.

FDA 510(k) clearance K133569 for TRUE DILATATION BALLOON VALVULOPLASTY CATHETER, 20MM X 4.5 CM, 22MM X 4.5CM, 24 MM X 4.5CM, 26MM X 4.5CM, Substantially Equivalent on 2013-12-20. Applicant: Bard Peripheral Vascular, Inc.. Device class: 2.

Clearance details

Applicant: Bard Peripheral Vascular, Inc.
Product code: Code OZT
Device class: Class 2
Regulation: 21 CFR 870.1255
Advisory panel: Cardiovascular
Date received: 2013-11-20
Decision date: 2013-12-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code OZT

product code OZT

Death: 20
Other: 2
Total: 22

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.