Endothelial Cell Harvesting Kit
The endothelial cell harvesting kit is a cardiovascular convenience kit used to harvest endothelial cells from veins for seeding onto vascular graft surfaces to improve biocompatibility and patency; it falls under FDA enforcement discretion per the May 1997 convenience kits interim regulatory guidance. It is classified as FDA Class II under 21 CFR 870.4075 within the Cardiovascular specialty, requiring 510(k) premarket clearance. The product code is MFY and the device is not implanted. Full GMP compliance is required.
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Basic Information
- Product Code
- MFY
- Device Class
- FDA class 2
- Regulation Number
- 870.4075
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 7
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K925608 | SCIMED ENCORE(TM) ADVANTAGE KIT/ESSENTIALS KIT | Jun 16, 1993 | Unknown | Scimed Life Systems, Inc. |
FEI Numbers
This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.