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510(k) K965214

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

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)

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