Clearance Summary
Super Sheath received FDA 510(k) clearance under submission number K200379, sponsored by Togo Medikit Co., Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2020-03-19.
- Submission: K200379
- Applicant / Sponsor: Togo Medikit Co., Ltd.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1310
- Decision date: 2020-03-19
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.