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510(k) K261808

ISAAC Neurovascular Navigation Catheter by Microvention Inc. d/b/a Terumo Neuro — Product Code QJP

K261808 is an FDA 510(k) premarket notification submitted by Microvention Inc. d/b/a Terumo Neuro for the device "ISAAC Neurovascular Navigation Catheter". The FDA issued a decision of Substantially Equivalent on June 30, 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
June 30, 2026
Date Received
June 1, 2026
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 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)
  • 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)
  • K254046 — BosCATH Support Catheter (April 21, 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