ASEPT® Glide Peritoneal Drainage System— 510(k) K241278

Name: FDA 510(k) clearance K241278
Creator: U.S. Food and Drug Administration
Published: 2025-01-14

Substantially Equivalent

Pfm Medical, Inc.

FDA 510(k) clearance K241278 for ASEPT® Glide Peritoneal Drainage System, Substantially Equivalent on 2025-01-14. 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: 2024-05-06
Decision date: 2025-01-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

Download summary PDF View on FDA.gov ↗

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K201155 — PleurX Peritoneal Catheter System2020-10-21

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