510(k) K910197

HYDROGEL-COATED URETHRAL CATHETERS AND DRAINS by C.R. Bard, Inc. — Product Code EZC

K910197 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "HYDROGEL-COATED URETHRAL CATHETERS AND DRAINS". The FDA issued a decision of Substantially Equivalent on August 9, 1991. The device falls under product code EZC (Catheter, Coude), a Class II device regulated under 21 CFR 876.5130. C.R. Bard, Inc. has at least 10 other 510(k) clearances on record.