Perifix FX Catheter; Contiplex FX Catheter— 510(k) K231242

Substantially Equivalent

B.Braun Medical, Inc.

FDA 510(k) clearance K231242 for Perifix FX Catheter; Contiplex FX Catheter, Substantially Equivalent on 2023-09-15. Applicant: B.Braun Medical, Inc..

Clearance details

Applicant: B.Braun Medical, Inc.
Product code: Code BSO
Advisory panel: Anesthesiology
Date received: 2023-05-01
Decision date: 2023-09-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Center Valley, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code BSO

product code BSO

Malfunction: 688
Total: 688

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.