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510(k) K123033

ROCKET IPC INSERTION PACK, ROCKET IPC MINI INSERTION SET, ROCKET IPC DRESSING PACK AND BOTTLE SET, ROCKET IPC DRAINAGE B by Rocket Medical Plc — Product Code DWM

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: February 1, 2013
Date Received: September 28, 2012
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

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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)
K163321 — Rocket Indwelling Pleural Catheter (IPC) Insertion Kit (August 17, 2017)
K160450 — Pleurx Pleural Catheter System (October 31, 2016)
K141965 — PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT (July 2, 2015)
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)