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510(k) K162457

Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit by Rocket Medical Plc — Product Code PNG

K162457 is an FDA 510(k) premarket notification submitted by Rocket Medical Plc for the device "Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit". The FDA issued a decision of Substantially Equivalent (kit, denovo) on November 14, 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. Rocket Medical Plc has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
November 14, 2016
Date Received
September 2, 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 Rocket Medical Plc

  • K210509 — Rocket Platinum Cured Cathter (September 9, 2021)
  • K163321 — Rocket Indwelling Pleural Catheter (IPC) Insertion Kit (August 17, 2017)
  • K152105 — Rocket IPC Insertion Set, Rocket IPC Mini Insertion Set (March 29, 2016)
  • K123033 — ROCKET IPC INSERTION PACK, ROCKET IPC MINI INSERTION SET, ROCKET IPC DRESSING PA (February 1, 2013)
  • K052365 — CERVINEEDLE DISPOSABLE CARTRIDGE SYRINGE (October 17, 2005)
  • K042264 — GUIDEWIRES (November 24, 2004)
  • K040189 — ENDOMETRIAL SAMPLING SYRINGE (October 4, 2004)
  • K032015 — EMBRYON ULTRASOUND NEEDLE GUIDE (August 8, 2003)
  • K000340 — HYSTALOG HSG CATHETER (April 19, 2000)
  • K000205 — EMBRYON SINGLE AND DOUBLE LUMEN NEEDLES (April 19, 2000)

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)
  • 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)

FDA data resources