ASEPT PERITONEAL DRAINAGE SYSTEM— 510(k) K093796

Unknown

Pfm Medical, Inc.

FDA 510(k) clearance K093796 for ASEPT PERITONEAL DRAINAGE SYSTEM, Unknown on 2010-02-26. Applicant: Pfm Medical, Inc.. Device class: 2.

Clearance details

Applicant: Pfm Medical, Inc.
Product code: Code PNG
Device class: Class 2
Regulation: 21 CFR 876.5630
Advisory panel: Gastroenterology, Urology
Date received: 2009-12-11
Decision date: 2010-02-26
Decision: Unknown
Clearance type: Traditional
Location: Oceanside, CA, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K093796

K-number listed on FDA's recall record

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 K093796.

Data sourced from openFDA. This site is unofficial and independent of the FDA.