MFY — Endothelial Cell Harvesting Kit Class II
FDA product code MFY covers "Endothelial Cell Harvesting Kit", a Class II medical device regulated under 21 CFR 870.4075. Submissions are reviewed by the Cardiovascular panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- MFY
- Device Class
- Class II
- Regulation Number
- 870.4075
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Definition
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K925608 | scimed life systems | SCIMED ENCORE(TM) ADVANTAGE KIT/ESSENTIALS KIT | June 16, 1993 |