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510(k) K810257

VESSEL TIPS, SIZES 13-18 by Quinton, Inc. — Product Code FKW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 1981
Date Received
January 30, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tip, Vessel
Device Class
Class II
Regulation Number
876.5540
Review Panel
GU
Submission Type

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  • 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 FKW

  • K893438 — T SERIES VESSEL TIPS (June 8, 1989)
  • K791645 — VICKERS MEDICAL MODEL 112 TREONIC DC2 (October 2, 1979)