Clearance Summary
PG Pro Microcatheter received FDA 510(k) clearance under submission number K192625, sponsored by MicroVention, Inc. A TERUMO Group Company. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2019-11-21.
- Submission: K192625
- Applicant / Sponsor: MicroVention, Inc. A TERUMO Group Company
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1250
- Decision date: 2019-11-21
Classification & Regulation
This clearance is catalogued under FDA product code DQY and 21 CFR 870.1250, within the Cardiovascular review panel as a Class II device.