Home / 510(k) Clearances / K972867

510(k) K972867

CRAFT DUO-VAC SUCTION UNIT, CRAFT SUCTION UNIT by Rocket Medical Plc — Product Code ICX

K972867 is an FDA 510(k) premarket notification submitted by Rocket Medical Plc for the device "CRAFT DUO-VAC SUCTION UNIT, CRAFT SUCTION UNIT". The FDA issued a decision of Substantially Equivalent on October 24, 1997. The device falls under product code ICX (Aniline), a Class I device regulated under 21 CFR 864.1850. Rocket Medical Plc has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 1997
Date Received
August 4, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Aniline
Device Class
Class I
Regulation Number
864.1850
Review Panel
PA
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)

FDA data resources