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510(k) K191469

Biotronik Stylets by Biotronik, Inc. — Product Code DRB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 2019
Date Received
June 3, 2019
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 Biotronik, Inc.

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  • K222037 — Selectra Lead Implantation System (July 19, 2022)
  • K214038 — Oscar Peripheral Multifunctional Catheter system (July 6, 2022)
  • K201445 — MultiCath, AcQRate Dx Fixed Curve Catheter (September 2, 2021)

Other clearances for product code DRB

  • K220280 — Arrow Stiffening Stylet (August 30, 2022)
  • 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)