510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K801027Substantially Equivalent

Mds Imager

Medtronic, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K801027 is the FDA 510(k) clearance record for MDS IMAGER, cleared for Medtronic Vascular on . FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show no recalls naming K801027.

Clearance record

Decision date
Received
(27 days to decision)
Review panel
Unknown
Applicant
Medtronic Vascular 4221 Richmond Rd., NW, Walker MI
Third party review
No