Clearance Summary
CARPENTER-EDWARDS CLASSIC RING WITH DURAFLO TREATMENT MODELS 4425 (MITRAL) AND 4525 (TRICUSPID), CARPENTER-EDWARDS PHYSM received FDA 510(k) clearance under submission number K980487, sponsored by Baxter Edwards. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1998-07-07.
- Submission: K980487
- Applicant / Sponsor: Baxter Edwards
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.3800
- Decision date: 1998-07-07
Classification & Regulation
This clearance is catalogued under FDA product code KRH and 21 CFR 870.3800, within the Cardiovascular review panel as a Class II device.