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510(k) K992664

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

K992664 is an FDA 510(k) premarket notification submitted by Tfx Medical Group for the device "TFX MEDICAL STYLET CATHETER". The FDA issued a decision of Substantially Equivalent on April 13, 2000. The device falls under product code DRB (Stylet, Catheter), a Class II device regulated under 21 CFR 870.1380. Tfx Medical Group has at least 2 other 510(k) clearances on record.

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)

Other clearances for product code DRB

  • K220280 — Arrow Stiffening Stylet (August 30, 2022)
  • K191469 — Biotronik Stylets (August 1, 2019)
  • K182660 — GaltTWS (May 30, 2019)
  • K170298 — Liberator Beacon Tip Locking Stylet (October 18, 2017)
  • K142116 — LLD EZ (August 12, 2014)
  • K090163 — STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078 (April 1, 2009)
  • K080924 — MOND RVOT STYLET MODELS 4140, 4141, 4150, 4151 (April 30, 2008)
  • 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)

FDA data resources