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510(k) K222065

Passeo-35 Xeo Peripheral Dilatation Catheter by Biotronik, Inc. — Product Code LIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 2023
Date Received
July 13, 2022
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.

  • K250706 — Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Ca (April 4, 2025)
  • K242969 — Pantera Pro; Pantera LEO (October 25, 2024)
  • K240787 — Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitte (September 12, 2024)
  • K241711 — Oscar Peripheral Multifunctional Catheter system (July 11, 2024)
  • K230375 — BIOMONITOR IV (May 19, 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)

Other clearances for product code LIT

  • K252512 — Armada™ 14 NC PTA Catheter (February 13, 2026)
  • K251915 — Amethyst HP PTA OTW 0.035 Catheter (December 18, 2025)
  • K250706 — Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Ca (April 4, 2025)
  • 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)