BD Prevue II Peripheral Vascular Vascular Access System— 510(k) K211193

Substantially Equivalent

Bard Access Systems, Inc. (C.R. Bard, Inc.)

FDA 510(k) clearance K211193 for BD Prevue II Peripheral Vascular Vascular Access System, Substantially Equivalent on 2021-06-25. Applicant: Bard Access Systems, Inc. (C.R. Bard, Inc.).

Clearance details

Applicant: Bard Access Systems, Inc. (C.R. Bard, Inc.)
Product code: Code IYO
Advisory panel: Radiology
Date received: 2021-04-21
Decision date: 2021-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake Ciy,, UT, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code IYO

product code IYO

Malfunction: 3,339
Total: 3,339

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.