AccuCath Ace Intravascular Catheter— 510(k) K233106

Substantially Equivalent

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

FDA 510(k) clearance K233106 for AccuCath Ace Intravascular Catheter, Substantially Equivalent on 2024-04-19. Applicant: Bard Access Systems, Inc. (C.R. Bard, Inc.).

Clearance details

Applicant: Bard Access Systems, Inc. (C.R. Bard, Inc.)
Product code: Code FOZ
Advisory panel: General Hospital
Date received: 2023-09-27
Decision date: 2024-04-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake Ciy,, UT, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FOZ

product code FOZ

Death: 38
Injury: 2,290
Malfunction: 25,858
Other: 11
Total: 28,197

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.