Clearance Summary
ATLANTIS SR, MODEL C4020; ATLANTIS SR PLUS, MODEL 35975 received FDA 510(k) clearance under submission number K040776, sponsored by Boston Scientific Corp. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2004-04-29.
- Submission: K040776
- Applicant / Sponsor: Boston Scientific Corp
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1200
- Decision date: 2004-04-29
Classification & Regulation
This clearance is catalogued under FDA product code DQO and 21 CFR 870.1200, within the Cardiovascular review panel as a Class II device.