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510(k) K214038

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 2022
Date Received
December 23, 2021
Clearance Type
Traditional
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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  • K241711 — Oscar Peripheral Multifunctional Catheter system (July 11, 2024)
  • 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)
  • K201445 — MultiCath, AcQRate Dx Fixed Curve Catheter (September 2, 2021)
  • K201865 — Biomonitor III, Biomonitor IIIm (December 8, 2020)

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  • K243704 — Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon D (February 27, 2025)
  • K241040 — Amethyst HP PTA OTW 0.035 Catheter (December 18, 2024)
  • K242419 — 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter (November 15, 2024)
  • K241740 — Finesse Injectable™ PTA Balloon Dilatation Catheter (July 16, 2024)
  • K241711 — Oscar Peripheral Multifunctional Catheter system (July 11, 2024)
  • K241683 — Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031404020 ); Sterling (July 10, 2024)
  • K241025 — JADE PLUS PTA Balloon Dilatation Catheter (June 11, 2024)