POWER-TRIALYSIS TRIPLE LUMEN ACUTE DIALYSIS CATHETER— 510(k) K083675

Substantially Equivalent

C.R. Bard, Inc.

FDA 510(k) clearance K083675 for POWER-TRIALYSIS TRIPLE LUMEN ACUTE DIALYSIS CATHETER, Substantially Equivalent on 2009-03-19. Applicant: C.R. Bard, Inc..

Clearance details

Applicant: C.R. Bard, Inc.
Product code: Code NIE
Advisory panel: Gastroenterology, Urology
Date received: 2008-12-11
Decision date: 2009-03-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake Ciy,, UT, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code NIE

product code NIE

Death: 9
Other: 1
Total: 10

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.