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510(k) K160437

PleurX Peritoneal Catheter System by Care Fusion — Product Code PNG

K160437 is an FDA 510(k) premarket notification submitted by Care Fusion for the device "PleurX Peritoneal Catheter System". The FDA issued a decision of Substantially Equivalent (kit, denovo) on November 3, 2016. 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. Care Fusion has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
November 3, 2016
Date Received
February 17, 2016
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 Care Fusion

  • K233021 — BD SmartSite™ 13mm Vial Access Device; BD SmartSite™ 20mm Vial Access Device (March 6, 2024)
  • K231888 — BD Texium™ Needle-Free Syringe (September 25, 2023)
  • K221327 — BD Alaris™ Pump Infusion Sets (July 21, 2023)
  • K221319 — BD Alaris™ Pump Epidural Infusion Set (July 21, 2023)
  • K223101 — BD Secondary Infusion Set (May 12, 2023)
  • K223088 — BD SmartSite™ Needle-Free Connector (April 7, 2023)
  • K223076 — BD Texium™ Closed Male Luer (March 24, 2023)
  • K201155 — PleurX Peritoneal Catheter System (October 21, 2020)
  • K170405 — BD Curve Ascites Shunt (November 2, 2017)
  • K171531 — Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow Bio (September 11, 2017)

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)
  • 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)

FDA data resources