FDA product code MFY: Endothelial Cell Harvesting Kit
MFY is the FDA product code for endothelial cell harvesting kit. It is a Class II device, regulated under 21 CFR 870.4075 and reviewed by the Cardiovascular panel. FDA has cleared 1 510(k) submission under MFY. The average 510(k) review took 223 days (median 223).
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.
Classification
| Field | Value |
|---|---|
| Device name | Endothelial Cell Harvesting Kit |
| Device class | Class II |
| Regulation | 21 CFR 870.4075 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every MFY clearance
Top MFY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Scimed Life Systems, Inc. | 1 | 1993-06-16 |
Most recent MFY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K925608 | Scimed Life Systems, Inc. | SCIMED ENCORE(TM) ADVANTAGE KIT/ESSENTIALS KIT | 1993-06-16 | 223 |
Recalls for MFY devices
openFDA lists no recalls for product code MFY.
Frequently asked questions
What is FDA product code MFY?
MFY is the FDA product code for endothelial cell harvesting kit. It is a Class II device, regulated under 21 CFR 870.4075 and reviewed by the Cardiovascular panel.
What device class is MFY?
Class II, regulation 21 CFR 870.4075. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code MFY?
Across 1 cleared submissions the average was 223 days from receipt to decision (median 223).
Which companies have the most MFY clearances?
Scimed Life Systems, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MFY
- Run a recall and safety report across every MFY manufacturer
- Watch product code MFY for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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