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510(k) K813428

SHUNT ADAPTER by Quinton, Inc. — Product Code FKN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 31, 1981
Date Received
December 8, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Adaptor, Shunt
Device Class
Class II
Regulation Number
876.5540
Review Panel
GU
Submission Type

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  • 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 FKN

  • K893478 — DA-16 AND DA-24 SHUNT ADAPTERS (June 8, 1989)
  • K892667 — SAF-T-SHUNT SILICONE RUBBER U, PROD. CODE S-313 (May 4, 1989)
  • K771425 — A-V SHUNT EXTENSION (January 3, 1978)