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510(k) K051711

PLEURX PERITONEAL CATHETER KIT AND PLEURX DRAINAGE KITS by Denver Biomedical, Inc. — Product Code PNG

K051711 is an FDA 510(k) premarket notification submitted by Denver Biomedical, Inc. for the device "PLEURX PERITONEAL CATHETER KIT AND PLEURX DRAINAGE KITS". The FDA issued a decision of Substantially Equivalent on November 15, 2005. 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. Denver Biomedical, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 2005
Date Received
June 27, 2005
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 Denver Biomedical, Inc.

  • K052436 — PLEURX PLEURAL CATHETER KIT, MODEL 50-7000 (October 6, 2005)
  • K012235 — DENVER PLEURAL EFFUSION SHUNT AND DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PU (October 4, 2001)
  • K011862 — DENVER ASCITES SHUNT AND PERCUTANEOUS ACCESS KIT WITH ASCITIES SHUNT (July 12, 2001)
  • K011831 — MODIFICATION TO PLEURX PLEURAL CATHETER AND DRAINAGE KITS (June 28, 2001)

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