Clearance Summary
RDI CARDIAC INSULATION PAD received FDA 510(k) clearance under submission number K960312, sponsored by R D Intl.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1996-04-19.
- Submission: K960312
- Applicant / Sponsor: R D Intl.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4475
- Decision date: 1996-04-19
Classification & Regulation
This clearance is catalogued under FDA product code DWP and 21 CFR 870.4475, within the Cardiovascular review panel as a Class II device.