Clearance Summary
TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guardian Motorized Dilator Sheath, 11 French (575-011); TightRail Guardian Motorized Dilator Sheath, 13 French (575-013) received FDA 510(k) clearance under submission number K223472, sponsored by Spectranetics, 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 2022-12-15.
- Submission: K223472
- Applicant / Sponsor: Spectranetics, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1310
- Decision date: 2022-12-15
Classification & Regulation
This clearance is catalogued under FDA product code DRE and 21 CFR 870.1310, within the Cardiovascular review panel as a Class II device.