
Zcv ,Inc.
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Z2 BALLOON GUIDED PACING & PRESSURE MONITORING CATHETER, MODEL Z2-7-02-1-10-0 is an FDA 510(k)-cleared medical device (K003118) manufactured by Zcv ,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 December 19, 2000. Regulation: 8.