510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K864637Substantially Equivalent

Modified Eschmann Dilatation Catheter

Eschmann Bros. & Walsh, Ltd., Sussex Bn15 8tj, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864637 is the FDA 510(k) clearance record for MODIFIED ESCHMANN DILATATION CATHETER, cleared for Eschmann Bros. & Walsh , Ltd. on . FDA records list 3 510(k) clearances for Eschmann Bros. & Walsh , Ltd., from to . As of , FDA records show no recalls naming K864637.

Clearance record

Decision date
Received
(48 days to decision)
Review panel
Unknown
Applicant
Eschmann Bros. & Walsh , Ltd. Peter Rd., Lancing, Sussex Bn15 8tj, GB
Third party review
No