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510(k) K220280

Arrow Stiffening Stylet by Arrow International, LLC (A subsidiary of Teleflex, Inc.) — Product Code DRB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 2022
Date Received
February 1, 2022
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 Arrow International, LLC (A subsidiary of Teleflex, Inc.)

  • K243599 — Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (EDC-00818) (March 14, 2025)
  • K242281 — Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00620); Arrow End (December 20, 2024)
  • K220363 — VPS Rhythm DLX Device with TipTracker Technology (August 22, 2022)

Other clearances for product code DRB

  • 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)
  • K043401 — SPECTRANETICS LLD CS, MODEL 518-039 (March 16, 2005)