Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
K863666Substantially Equivalent

The Saver Kit

Myocure, Inc., Glendale CA / Traditional, Substantially Equivalent

K863666 is the FDA 510(k) clearance record for THE SAVER KIT, cleared for Myocure, Inc. on . FDA records list 15 510(k) clearances for Myocure, Inc., from to . As of , FDA records show no recalls naming K863666.

Clearance record

Decision date
Received
(32 days to decision)
Review panel
Unknown
Applicant
Myocure, Inc. 1736 Flower St., Glendale CA
Third party review
No