VETA PERITONEAL DIALYSIS CATHETER— 510(k) K113354

Unknown

Pfm Medical, Inc.

FDA 510(k) clearance K113354 for VETA PERITONEAL DIALYSIS CATHETER, Unknown on 2012-03-13. Applicant: Pfm Medical, Inc..

Clearance details

Applicant: Pfm Medical, Inc.
Product code: Code FJS
Advisory panel: Gastroenterology, Urology
Date received: 2011-11-14
Decision date: 2012-03-13
Decision: Unknown
Clearance type: Traditional
Location: Carlsbad, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FJS

product code FJS

Death: 34
Injury: 652
Malfunction: 576
Other: 6
Total: 1,268

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.