Clearance Summary
R2P Destination Slender Guiding Sheath received FDA 510(k) clearance under submission number K193125, sponsored by Terumo Medical Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2020-01-06.
- Submission: K193125
- Applicant / Sponsor: Terumo Medical Corporation
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1340
- Decision date: 2020-01-06
Classification & Regulation
This clearance is catalogued under FDA product code DYB and 21 CFR 870.1340, within the Cardiovascular review panel as a Class II device.