
Mallinckroot, Inc.
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COPPERHEAD 5 FR. PTA CATHETER, FINCH 4 FR. PTA CATHETER is an FDA 510(k)-cleared medical device (K983830) manufactured by Mallinckroot, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 15, 1999. Regulation: 8.

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