CROSSER CTO Recanalization Catheter— 510(k) K161208

Name: FDA 510(k) clearance K161208
Creator: U.S. Food and Drug Administration
Published: 2016-05-24

Substantially Equivalent

Bard Peripheral Vacular, Inc.

FDA 510(k) clearance K161208 for CROSSER CTO Recanalization Catheter, Substantially Equivalent on 2016-05-24. Applicant: Bard Peripheral Vacular, Inc.. Device class: 2.

Clearance details

Applicant: Bard Peripheral Vacular, Inc.
Product code: Code PDU
Device class: Class 2
Regulation: 21 CFR 870.1250
Advisory panel: Cardiovascular
Date received: 2016-04-28
Decision date: 2016-05-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Tempe, AZ, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code PDU

product code PDU

Malfunction: 793
Total: 793

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.