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510(k) K254223

Next Generation 088 Catheter by Balt USA, LLC — Product Code QJP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 2026
Date Received
December 29, 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 by Balt USA, LLC

  • K254221 — Optima Coil System (OptiOne Coil System) (January 27, 2026)
  • K252569 — Carrier XL Delivery Catheter (October 22, 2025)
  • K252700 — Optima Coil System (Optima Packing Coil System) (September 26, 2025)
  • K243948 — Raptor Aspiration Catheter; Balt Aspiration Tubing Set (June 3, 2025)
  • K251383 — Prestige Coil System (Prestige Packing Line Extension) (May 30, 2025)
  • K242376 — Next Generation Access Platform (December 30, 2024)
  • K242582 — Optima Coil System (OptiBlock Line Extension) (September 27, 2024)
  • K234083 — Next Generation Aspiration Catheter; Balt Aspiration Tubing Set (July 2, 2024)
  • K234074 — Next Generation Access Catheter (July 2, 2024)
  • K230609 — NG Delivery Catheter (September 13, 2023)

Other clearances for product code QJP

  • K260938 — PATH BGC (April 15, 2026)
  • K253975 — Radical 6F Access Catheter (April 9, 2026)
  • 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)