Provena(TM) Midline Catheter— 510(k) K213203

Substantially Equivalent

C.R. Bard, Inc.

FDA 510(k) clearance K213203 for Provena(TM) Midline Catheter, Substantially Equivalent on 2022-05-13. Applicant: C.R. Bard, Inc..

Clearance details

Applicant: C.R. Bard, Inc.
Product code: Code PND
Advisory panel: General Hospital
Date received: 2021-09-29
Decision date: 2022-05-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Salt Lake Ciy,, UT, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code PND

product code PND

Injury: 149
Malfunction: 695
Other: 1
Total: 845

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.