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510(k) K801680

BETA-CAP II ADAPTER by Quinton, Inc. — Product Code GCE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 1980
Date Received
July 22, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Adaptor, Catheter
Device Class
Class I
Regulation Number
878.4200
Review Panel
SU
Submission Type

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  • K971397 — VIEWCATH 3-D CATHETER PULLBACK (August 25, 1997)
  • K964784 — SYNERGY CARDIOLOGY INFORMATION SYSTEM (00431) (August 13, 1997)
  • K964978 — VITAL STATISTICS SYSTEM (O-CATH ACCESSORY) (May 21, 1997)
  • K955002 — MAHURKAR 8 FR DUAL LEMEN CATHETER (September 13, 1996)

Other clearances for product code GCE

  • K901716 — KLEIN CONNECTOR(TM) (May 11, 1990)
  • K901715 — KLEIN CORK(TM) (May 11, 1990)
  • K855039 — MEDIFLEX INJECTION CAP (January 24, 1986)