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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K833742Substantially Equivalent

Eschmann Dilation Catheter

Vertex Medical Corp., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K833742 is the FDA 510(k) clearance record for ESCHMANN DILATION CATHETER, cleared for Vertex Medical Corp. on . FDA records list 21 510(k) clearances for Vertex Medical Corp., from to . As of , FDA records show no recalls naming K833742.

Clearance record

Decision date
Received
(181 days to decision)
Review panel
Unknown
Applicant
Vertex Medical Corp. 4221 Richmond Rd., NW, Walker MI
Third party review
No