Clearance Summary
GT1 FLOPPY, GT1 HI-PER FLEX, GT1 LIGHT SUPPORT received FDA 510(k) clearance under submission number K983927, sponsored by Arterial Vascular Engineering, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1999-03-11.
- Submission: K983927
- Applicant / Sponsor: Arterial Vascular Engineering, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1370
- Decision date: 1999-03-11
Classification & Regulation
This clearance is catalogued under FDA product code DQT and 21 CFR 870.1370, within the Cardiovascular review panel as a Class II device.