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510(k) K163321

Rocket Indwelling Pleural Catheter (IPC) Insertion Kit by Rocket Medical Plc — Product Code DWM

K163321 is an FDA 510(k) premarket notification submitted by Rocket Medical Plc for the device "Rocket Indwelling Pleural Catheter (IPC) Insertion Kit". The FDA issued a decision of Substantially Equivalent on August 17, 2017. The device falls under product code DWM (Apparatus, Suction, Patient Care), a Class II device regulated under 21 CFR 870.5050. Rocket Medical Plc has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 2017
Date Received
November 25, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Suction, Patient Care
Device Class
Class II
Regulation Number
870.5050
Review Panel
AN
Submission Type

Other clearances by Rocket Medical Plc

  • K210509 — Rocket Platinum Cured Cathter (September 9, 2021)
  • K162457 — Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit (November 14, 2016)
  • 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)
  • K000205 — EMBRYON SINGLE AND DOUBLE LUMEN NEEDLES (April 19, 2000)
  • K000340 — HYSTALOG HSG CATHETER (April 19, 2000)

Other clearances for product code DWM

  • K212696 — Aspira Pleural Drainage System (March 3, 2023)
  • K210509 — Rocket Platinum Cured Cathter (September 9, 2021)
  • K201404 — Passio Pump Drainage System (November 20, 2020)
  • K190292 — Passio Pump Drainage System (July 25, 2019)
  • K160450 — Pleurx Pleural Catheter System (October 31, 2016)
  • K141965 — PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT (July 2, 2015)
  • K123033 — ROCKET IPC INSERTION PACK, ROCKET IPC MINI INSERTION SET, ROCKET IPC DRESSING PA (February 1, 2013)
  • K121849 — PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT, PLEURX CATHETER INSE (October 18, 2012)
  • K112831 — PLEURX PLEURAL CATHETER SYSTEMS (February 16, 2012)
  • K110409 — ASPIRA PLEURAL DRAINAGE SYSTEM (May 11, 2011)

FDA data resources