Home / 510(k) Clearances / K261549

510(k) K261549

BOBBY Balloon Guide Catheter by MicroVention, Inc., d/b/a Terumo Neuro — Product Code QJP

K261549 is an FDA 510(k) premarket notification submitted by MicroVention, Inc., d/b/a Terumo Neuro for the device "BOBBY Balloon Guide Catheter". The FDA issued a decision of Substantially Equivalent on June 9, 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 9, 2026
Date Received
May 11, 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)
  • K261808 — ISAAC Neurovascular Navigation Catheter (June 30, 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