Clearance Summary
THE WAND MICROACCESS SAFETY INTRODUCER, MODELS 90001, 90002, 90005, 90006 received FDA 510(k) clearance under submission number K081697, sponsored by Access Scientific, 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 2008-12-04.
- Submission: K081697
- Applicant / Sponsor: Access Scientific, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1340
- Decision date: 2008-12-04
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.