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510(k) K241711

Oscar Peripheral Multifunctional Catheter system by Biotronik, Inc. — Product Code LIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 2024
Date Received
June 14, 2024
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Angioplasty, Peripheral, Transluminal
Device Class
Class II
Regulation Number
870.1250
Review Panel
CV
Submission Type

Other clearances by Biotronik, Inc.

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  • K230375 — BIOMONITOR IV (May 19, 2023)
  • K222065 — Passeo-35 Xeo Peripheral Dilatation Catheter (February 16, 2023)
  • K221856 — BIOMONITOR IIIm, BIOMONITOR III (July 27, 2022)
  • 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)
  • K201865 — Biomonitor III, Biomonitor IIIm (December 8, 2020)

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