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510(k) K254046

BosCATH Support Catheter by Sonorous NV, Inc. — Product Code QJP

K254046 is an FDA 510(k) premarket notification submitted by Sonorous NV, Inc. for the device "BosCATH Support Catheter". The FDA issued a decision of Substantially Equivalent on April 21, 2026. The device falls under product code QJP (Catheter, Percutaneous, Neurovasculature), a Class II device regulated under 21 CFR 870.1250.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 2026
Date Received
December 17, 2025
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 for product code QJP

  • K260199 — SLIM Microcatheter (July 13, 2026)
  • K253901 — Millipede88 Access Catheter (July 9, 2026)
  • K261889 — Trevo Trak 21 Microcatheter (July 1, 2026)
  • K261808 — ISAAC Neurovascular Navigation Catheter (June 30, 2026)
  • K261549 — BOBBY Balloon Guide Catheter (June 9, 2026)
  • K253359 — Zenith Distal Access Long Sheath (May 22, 2026)
  • K254178 — SAYA 86 Radial Access Guide Catheter (May 11, 2026)
  • K254223 — Next Generation 088 Catheter (April 16, 2026)
  • K260938 — PATH BGC (April 15, 2026)
  • K253975 — Radical 6F Access Catheter (April 9, 2026)

FDA data resources