510(k) K003118

Z2 BALLOON GUIDED PACING & PRESSURE MONITORING CATHETER, MODEL Z2-7-02-1-10-0 by Zcv ,Inc. — Product Code DYG

K003118 is an FDA 510(k) premarket notification submitted by Zcv ,Inc. for the device "Z2 BALLOON GUIDED PACING & PRESSURE MONITORING CATHETER, MODEL Z2-7-02-1-10-0". The FDA issued a decision of Substantially Equivalent on December 20, 2000. The device falls under product code DYG (Catheter, Flow Directed), a Class II device regulated under 21 CFR 870.1240. Zcv ,Inc. has at least 5 other 510(k) clearances on record.