Clearance Summary
TSP Crosser Transseptal Access System received FDA 510(k) clearance under submission number K181088, sponsored by Transseptal Solutions , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2018-09-28.
- Submission: K181088
- Applicant / Sponsor: Transseptal Solutions , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1340
- Decision date: 2018-09-28
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.