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510(k) K992664

TFX MEDICAL STYLET CATHETER by Tfx Medical Group — Product Code DRB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 13, 2000
Date Received
August 9, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stylet, Catheter
Device Class
Class II
Regulation Number
870.1380
Review Panel
CV
Submission Type

Other clearances by Tfx Medical Group

  • K991647 — TFX MEDICAL INTRODUCER KIT (January 4, 2000)
  • K963320 — TFX MEDICAL GUIDEWIRE (December 3, 1996)

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  • K072864 — ST. JUDE MEDICAL, CPS DUO LEFT HEART LEAD DELIVERY SYSTEM (March 13, 2008)
  • K053019 — ACUITY STEERABLE STYLET ACCESSORY (March 3, 2006)
  • K052965 — EASYTRAK 2 STYLET, MODELS 4826, 4829, 4832. (February 13, 2006)