POLYSTAN TWO STAGE CATHETERS

POLYSTAN TWO STAGE CATHETERS is an FDA 510(k)-cleared medical device (K874853) manufactured by Polystan C/O Vitalcor, 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 February 4, 1988. Regulation: 8.