Product code MFY— Cardiovascular
SCIMED ENCORE(TM) ADVANTAGE KIT/ESSENTIALS KIT
- Classification name
- Endothelial Cell Harvesting Kit
- Device class
- Class 2
- Regulation
- 21 CFR 870.4075
- Advisory panel
- Cardiovascular
- Total cleared
- 1
- First cleared
- Most recent
FDA classification 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.”
Market context for product code MFY
FDA has cleared device under product code MFY, all in 1993, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Top applicants under product code MFY
Recent clearances under product code MFY
Data sourced from openFDA. This site is unofficial and independent of the FDA.