
Leadoptik, Inc.
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LIA-1 Catheter (542-1) is an FDA 510(k)-cleared medical device (K251402) manufactured by Leadoptik, Inc.. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 18, 2025. Regulation: 8.

Ansell
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McKesson
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Hollister
SKU VM-1270031