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510(k) K771422

PATIENT BY-PASS by Quinton, Inc. — Product Code FJQ

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
Connector, Shunt
Device Class
Class I
Regulation Number
876.5540
Review Panel
GU
Submission Type

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  • K001492 — QUINTON Q-STRESS, MODEL 000483 (August 9, 2000)
  • 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 FJQ

  • K893679 — SHUNT CONNECTORS (July 24, 1989)
  • K771429 — DISP. TEFLON CONNHCTOR (December 22, 1977)