
NuMED, Inc.
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MODIFICATION TO NUMED TYSHAK II AND Z-MED II PTV CATHETERS is an FDA 510(k)-cleared medical device (K030589) manufactured by NuMED, 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 May 20, 2003. Regulation: 8.