Clearance Summary
MODEL 352-01 SILICONE RUBBER ISOLATION SLEEVE received FDA 510(k) clearance under submission number K863418, sponsored by Intermedics, 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 1986-09-24.
- Submission: K863418
- Applicant / Sponsor: Intermedics, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class III
- Regulation citation: 21 CFR 870.3610
- Decision date: 1986-09-24
Classification & Regulation
This clearance is catalogued under FDA product code DXY and 21 CFR 870.3610, within the Cardiovascular review panel as a Class III device.