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510(k) K241768

Broadway 8 Catheter by Stryker Neurovascular — Product Code QJP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2024
Date Received
June 20, 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

Other clearances by Stryker Neurovascular

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  • K251832 — InZone IST Detachment System; IZDS Connecting Cable (October 17, 2025)
  • K242289 — Excelsior XT-27 Microcatheter, Excelsior XT-27 Flex Microcatheter, Excelsior XT- (March 21, 2025)
  • K243593 — AXS Lift Intracranial Base Catheter (February 18, 2025)
  • K241637 — Echo Intracranial Base Catheter (December 19, 2024)
  • K223305 — Trevo NXT ProVue Retriever (March 29, 2023)
  • K222533 — Target Tetra Detachable Coils (December 14, 2022)
  • K211594 — Trevo Trak 21 Microcatheter (November 26, 2021)
  • K212455 — InZone Detachment System (November 16, 2021)

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)