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510(k) K240711

Zipline Access Catheter by Perfuze, Ltd. — Product Code QJP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 2024
Date Received
March 15, 2024
Clearance Type
Traditional
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

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  • K233648 — Millipede 088 Access Catheter (December 14, 2023)
  • 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

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  • 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)