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510(k) K093796

ASEPT PERITONEAL DRAINAGE SYSTEM by Pfm Medical, Inc. — Product Code PNG

K093796 is an FDA 510(k) premarket notification submitted by Pfm Medical, Inc. for the device "ASEPT PERITONEAL DRAINAGE SYSTEM". The FDA issued a decision of Substantially Equivalent (kit) on February 26, 2010. The device falls under product code PNG (Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling), a Class II device regulated under 21 CFR 876.5630. Pfm Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
February 26, 2010
Date Received
December 11, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling
Device Class
Class II
Regulation Number
876.5630
Review Panel
GU
Submission Type

For drainage of refractory ascites with long-term occurrence from the peritoneal cavity.

Other clearances by Pfm Medical, Inc.

  • K242763 — JetCan® Pro Safety Huber Needle (May 2, 2025)
  • K241278 — ASEPT® Glide Peritoneal Drainage System (January 14, 2025)
  • K221779 — ASEPT Peritoneal Drainage System (May 2, 2023)
  • K213666 — NuCath Wedge Pressure Catheter (October 6, 2022)
  • K201137 — Asept Surgical Face Mask (August 19, 2020)
  • K192802 — primeMidline Catheters (October 28, 2019)
  • K173114 — primeMidline Catheters (March 7, 2018)
  • K140137 — SAFETY BIOPSY NEEDLE SYSTEM (March 25, 2014)
  • K122402 — LPP (LOW PROFILE PORT) (July 16, 2013)
  • K113354 — VETA PERITONEAL DIALYSIS CATHETER (March 13, 2012)

Other clearances for product code PNG

  • K241278 — ASEPT® Glide Peritoneal Drainage System (January 14, 2025)
  • K241946 — PeritX™ 1L Drainage Kit (90-1010); PeritX™ 2L Drainage Kit (90-2010); PeritX™ Pe (December 6, 2024)
  • K230319 — Passio Pump Drainage System (November 24, 2023)
  • K221779 — ASEPT Peritoneal Drainage System (May 2, 2023)
  • K212675 — Aspira Peritoneal Drainage System (December 14, 2021)
  • K201155 — PleurX Peritoneal Catheter System (October 21, 2020)
  • K162457 — Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit (November 14, 2016)
  • K160437 — PleurX Peritoneal Catheter System (November 3, 2016)
  • K152105 — Rocket IPC Insertion Set, Rocket IPC Mini Insertion Set (March 29, 2016)
  • K122422 — PLEURX PLEURAL CATHETER SYSTEM PLEURX CATHETER ACCESS KIT PLEURX SLIDE VALVED PE (October 24, 2012)

FDA data resources