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510(k) K890292

PCA-10, 10CC DISP. ANGIOGRAPHY CONTROL SYRINGE by Coeur Laboratories, Inc. — Product Code DXT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1989
Date Received
January 19, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Injector And Syringe, Angiographic
Device Class
Class II
Regulation Number
870.1650
Review Panel
HO
Submission Type

Other clearances by Coeur Laboratories, Inc.

  • K971712 — COEUR 130 ML ANGIOGRAPHIC SYRINGE (October 8, 1997)
  • K965214 — COEUR FRONT LOAD INJECTOR RETROFIT KIT (C859-0002) (March 28, 1997)
  • K960965 — FRONT LOAD INJECTOR TURRET MODEL 859-0001/200 ML FRONT LOAD SYRINGE MODEL 853-02 (September 12, 1996)
  • 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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