Clearance Summary
BI-DIRECTIONAL TUNNELER received FDA 510(k) clearance under submission number K991027, sponsored by Impra, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1999-04-22.
- Submission: K991027
- Applicant / Sponsor: Impra, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.3450
- Decision date: 1999-04-22
Classification & Regulation
This clearance is catalogued under FDA product code DSY and 21 CFR 870.3450, within the Cardiovascular review panel as a Class II device.