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510(k) K965214

COEUR FRONT LOAD INJECTOR RETROFIT KIT (C859-0002) by Coeur Laboratories, Inc. — Product Code DTX

K965214 is an FDA 510(k) premarket notification submitted by Coeur Laboratories, Inc. for the device "COEUR FRONT LOAD INJECTOR RETROFIT KIT (C859-0002)". The FDA issued a decision of Substantially Equivalent on March 28, 1997. The device falls under product code DTX (Gas Control Unit, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4300. Coeur Laboratories, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 1997
Date Received
December 30, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gas Control Unit, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4300
Review Panel
CV
Submission Type

Other clearances by Coeur Laboratories, Inc.

  • K971712 — COEUR 130 ML ANGIOGRAPHIC SYRINGE (October 8, 1997)
  • K960965 — FRONT LOAD INJECTOR TURRET MODEL 859-0001/200 ML FRONT LOAD SYRINGE MODEL 853-02 (September 12, 1996)
  • K890292 — PCA-10, 10CC DISP. ANGIOGRAPHY CONTROL SYRINGE (June 22, 1989)
  • K885138 — CAPILLARY TUBE, BLOOD COLLECTION (February 7, 1989)
  • K885202 — 16 LONG CATHETER W/ADAPTER, 14 FR AND 12 FR (January 31, 1989)
  • K881646 — UROLOGICAL CATHETER (June 16, 1988)
  • K874579 — COEUR CONTROL SYRINGE (January 19, 1988)
  • K873597 — TUBING, POLYETHYLENE (November 12, 1987)
  • K823920 — COEURLOCK STERILE DISPOS. ANGIOGRAPHIC (February 18, 1983)

Other clearances for product code DTX

  • K210669 — Quantum Mini Ventilation Module (May 4, 2021)
  • K202733 — Quantum Ventilation Module (October 16, 2020)
  • K181942 — Quantum Ventilation Module (October 18, 2018)
  • K101046 — STOCKERT S5 SYSTEM AND GAS BLENDER AND SORIN C5 SYSTEM (December 9, 2010)
  • K023745 — SECHRIST AIR/OXYGEN MIXER, MODEL 3500 CP-G (January 17, 2003)
  • K863902 — MODIFIED SARNS MEMBRANE OXYGENATOR (December 11, 1986)
  • K822820 — GAS-FLOW METER GFL 10 (October 18, 1982)
  • K792348 — STANICOR, OMNI-STAN,MOD 333B,334A GAMMA (December 5, 1979)
  • K790546 — FLOWMETER, OPTIFLO GAS (May 11, 1979)

FDA data resources