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510(k) K991647

TFX MEDICAL INTRODUCER KIT by Tfx Medical Group — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 4, 2000
Date Received
May 13, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Introducer, Catheter
Device Class
Class II
Regulation Number
870.1340
Review Panel
CV
Submission Type

Other clearances by Tfx Medical Group

  • K992664 — TFX MEDICAL STYLET CATHETER (April 13, 2000)
  • K963320 — TFX MEDICAL GUIDEWIRE (December 3, 1996)

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