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510(k) K961287

ROCKET PLEURASEAL II CHEST DRAINAGE SYSTEM by Rocket Medical Plc — Product Code KDQ

K961287 is an FDA 510(k) premarket notification submitted by Rocket Medical Plc for the device "ROCKET PLEURASEAL II CHEST DRAINAGE SYSTEM". The FDA issued a decision of Substantially Equivalent on July 26, 1996. The device falls under product code KDQ (Bottle, Collection, Vacuum), a Class II device regulated under 21 CFR 880.6740. Rocket Medical Plc has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 1996
Date Received
April 3, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bottle, Collection, Vacuum
Device Class
Class II
Regulation Number
880.6740
Review Panel
HO
Submission Type

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)
  • 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)

Other clearances for product code KDQ

  • K081718 — EXPRESS CHEST DRAIN (July 25, 2008)
  • K062302 — MILLICORE AB DIGIVENT CHEST DRAINAGE SYSTEM (October 6, 2006)
  • K043582 — OCEAN CHEST DRAIN (January 21, 2005)
  • K984496 — ATRIUM MEDICAL CORPORATION EXPRESS CHEST DRAIN (May 5, 1999)
  • K962856 — PLEUR-EVAC SAHARA ADULT/PEDIATRIC CHEST DRAINAGE SYSTEM MODEL S-1100, S-1200, 2- (August 28, 1996)
  • K962168 — MUCUS SPECIMEN TRAP (July 22, 1996)
  • K950677 — ATRIUM DRY SUCTION CONTROL WATER SEAL CHEST DRAIN (April 13, 1995)
  • K941818 — PM9000 VAC TRAP (December 12, 1994)
  • K932327 — THORA-KLEX 350 ML PEDIATRIC CHEST DRAINAGE SYSTEM (July 13, 1993)
  • K912704 — ATRIUM 2000 CHEST DRAIN (August 26, 1991)

FDA data resources