Home / 510(k) Clearances / K212675

510(k) K212675

Aspira Peritoneal Drainage System by Merit Medical Systems, Inc. — Product Code PNG

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
December 14, 2021
Date Received
August 24, 2021
Clearance Type
Special
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 Merit Medical Systems, Inc.

  • K251802 — STAR RF Ablation System (February 13, 2026)
  • K252892 — SCOUT MD Surgical Guidance System (December 19, 2025)
  • K250853 — Merit Syringe (November 4, 2025)
  • K251265 — Resilience Fully Covered Esophageal Stent System (July 23, 2025)
  • K250909 — Prelude Wave Hydrophilic Sheath Introducer (April 25, 2025)
  • K242873 — Ventrax™ Delivery System (January 15, 2025)
  • K242229 — Micro Ace Gold Advanced Micro Access System (January 15, 2025)
  • K241521 — Prelude Small O.D. Introducer Guide Wire (December 10, 2024)
  • K233268 — Impress Angiographic Catheter (May 22, 2024)
  • K240261 — Siege Vascular Plug (SVP2.5-0.021); Siege Vascular Plug (SVP4-0.021); Siege Vasc (May 2, 2024)

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)
  • 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)
  • K113854 — PLEURX PERITONEAL CATHETER SYSTEM (March 19, 2012)