510(k) K974419

RUSCH SIMPLASTIC COUNCILL TIP CATHETER by Rusch, Inc. — Product Code EZL

K974419 is an FDA 510(k) premarket notification submitted by Rusch, Inc. for the device "RUSCH SIMPLASTIC COUNCILL TIP CATHETER". The FDA issued a decision of Substantially Equivalent on January 27, 1998. The device falls under product code EZL (Catheter, Retention Type, Balloon), a Class II device regulated under 21 CFR 876.5130. Rusch, Inc. has at least 10 other 510(k) clearances on record.