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510(k) K963320

TFX MEDICAL GUIDEWIRE by Tfx Medical Group — Product Code DQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 1996
Date Received
August 23, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wire, Guide, Catheter
Device Class
Class II
Regulation Number
870.1330
Review Panel
CV
Submission Type

Other clearances by Tfx Medical Group

  • K992664 — TFX MEDICAL STYLET CATHETER (April 13, 2000)
  • K991647 — TFX MEDICAL INTRODUCER KIT (January 4, 2000)

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