510(k) K832396

CENTRAL VENOUS ACCESS CATHETER CVAC by Gish Biomedical, Inc. — Product Code DOY

K832396 is an FDA 510(k) premarket notification submitted by Gish Biomedical, Inc. for the device "CENTRAL VENOUS ACCESS CATHETER CVAC". The FDA issued a decision of Substantially Equivalent on August 31, 1983. The device falls under product code DOY (Radioimmunoassay, Digoxin (3-H), Goat Antibody, 2nd Antibody Sep.), a Class II device regulated under 21 CFR 862.3320. Gish Biomedical, Inc. has at least 10 other 510(k) clearances on record.