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510(k) K000366

FIXATION STYLETS, MODELS 335-287 AND 335-288 by Accufix Research Institute — Product Code DRB

K000366 is an FDA 510(k) premarket notification submitted by Accufix Research Institute for the device "FIXATION STYLETS, MODELS 335-287 AND 335-288". The FDA issued a decision of Substantially Equivalent on April 14, 2000. The device falls under product code DRB (Stylet, Catheter), a Class II device regulated under 21 CFR 870.1380.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 2000
Date Received
February 4, 2000
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

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  • 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