Endothelial Cell Harvesting Kit
FDA product code MFY · Class II (moderate risk) · 21 CFR 870.4075 · Cardiovascular
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
1510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K925608 | Scimed Encore(Tm) Advantage Kit/Essentials KitMFY · Traditional | Scimed Life Systems, Inc. | 06/16/1993SESK |