VETA PERITONEAL DIALYSIS CATHETER— 510(k) K113354

Clearance details

Applicant

Pfm Medical, Inc.

Product code

Code FJS

Device class

Class 2

Regulation

21 CFR 876.5630

Advisory panel

Gastroenterology, Urology

Date received

2011-11-14

Decision date

2012-03-13

Decision

Unknown

Clearance type

Traditional

Location

Carlsbad, CA, US

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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 →

• Z-0568-2015 — ASEPT 2000 ml Drainage Bag, Ref No. 622280 Product Usage: The ASEPT Drainage Bag is to be used for peritoneal drainage with the ASEPT Peritoneal Drainage Catheter only.Class II·Terminated·Pfm Medical Inc·20141020

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K113354.