Clearance Summary
BOBBY Balloon Guide Catheter received FDA 510(k) clearance under submission number K261549, sponsored by MicroVention, Inc., d/b/a Terumo Neuro. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2026-06-09.
- Submission: K261549
- Applicant / Sponsor: MicroVention, Inc., d/b/a Terumo Neuro
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1250
- Decision date: 2026-06-09
Classification & Regulation
This clearance is catalogued under FDA product code QJP and 21 CFR 870.1250, within the Cardiovascular review panel as a Class II device.