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510(k) K771425

A-V SHUNT EXTENSION by Quinton, Inc. — Product Code FKN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 1978
Date Received
August 1, 1977
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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  • K992908 — Q-TEL TELEMETRY SYSTEM V. 6.0 (ST) (March 6, 2000)
  • K990866 — QUINTON MEDTRACK CR PLUS TREADMILL (April 29, 1999)
  • 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 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)
  • K813428 — SHUNT ADAPTER (December 31, 1981)