Ultraverse 014 and 018 PTA Balloon Dilatation Catheters— 510(k) K192318

Name: FDA 510(k) clearance K192318
Creator: U.S. Food and Drug Administration
Published: 2019-10-03

Substantially Equivalent

Bard Peripheral Vascular, Inc.

FDA 510(k) clearance K192318 for Ultraverse 014 and 018 PTA Balloon Dilatation Catheters, Substantially Equivalent on 2019-10-03. Applicant: Bard Peripheral Vascular, Inc.. Device class: 2.

Clearance details

Applicant: Bard Peripheral Vascular, Inc.
Product code: Code LIT
Device class: Class 2
Regulation: 21 CFR 870.1250
Advisory panel: Cardiovascular
Date received: 2019-08-26
Decision date: 2019-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tempe, AZ, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LIT

product code LIT

Death: 27
Injury: 1,256
Malfunction: 12,127
Total: 13,410

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.