Clearance Summary
STEERABLE RETROGRADE CARDIOPLEGIA CANNULA WITH AND WITHOUT DURAFLO TREATMENT, MODELS SRCO14MIB, DIISRCO14MIB received FDA 510(k) clearance under submission number K001565, sponsored by Edwards Lifesciences, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2000-08-10.
- Submission: K001565
- Applicant / Sponsor: Edwards Lifesciences, LLC
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4210
- Decision date: 2000-08-10
Classification & Regulation
This clearance is catalogued under FDA product code DWF and 21 CFR 870.4210, within the Cardiovascular review panel as a Class II device.