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510(k) K233648

Millipede 088 Access Catheter by Perfuze, Ltd. — Product Code QJP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 14, 2023
Date Received
November 14, 2023
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Percutaneous, Neurovasculature
Device Class
Class II
Regulation Number
870.1250
Review Panel
NE
Submission Type

To provide vascular access to the neurovasculature for interventional or diagnostic procedures

Other clearances by Perfuze, Ltd.

  • K252392 — Millipede70 Aspiration Catheter; Perfuze Aspiration Tube Set (August 29, 2025)
  • K250012 — Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set (February 26, 2025)
  • K240711 — Zipline Access Catheter (October 17, 2024)
  • K242504 — Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter; Perfuze Aspira (September 20, 2024)
  • K232524 — Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set (October 18, 2023)
  • K231802 — Millipede 088 Access Catheter (September 19, 2023)
  • K214048 — Millipede 088 Access Catheter (September 20, 2022)

Other clearances for product code QJP

  • K253032 — AXS Lift Intracranial Base Catheter (February 11, 2026)
  • K252297 — Toro 88 Superbore Catheter (January 16, 2026)
  • K251097 — V-DAC Catheter (January 6, 2026)
  • K251668 — SurfRider 13 Microcatheter (January 5, 2026)
  • K252213 — Bendit17 Microcatheter (December 3, 2025)
  • K251372 — VersaD Delivery Catheter (October 24, 2025)
  • K252569 — Carrier XL Delivery Catheter (October 22, 2025)
  • K250960 — DUO Microcatheter (September 8, 2025)
  • K251560 — FUBUKI XF-R Neurovascular Long Sheath (June 20, 2025)
  • K251240 — Branchor X Balloon Guide Catheter (June 20, 2025)