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510(k) K241278

ASEPT® Glide Peritoneal Drainage System by Pfm Medical, Inc. — Product Code PNG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 2025
Date Received
May 6, 2024
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.

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  • 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)
  • K110914 — TRIPLE LUMEN PFM PICC (September 21, 2011)

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  • K122422 — PLEURX PLEURAL CATHETER SYSTEM PLEURX CATHETER ACCESS KIT PLEURX SLIDE VALVED PE (October 24, 2012)
  • K113854 — PLEURX PERITONEAL CATHETER SYSTEM (March 19, 2012)