510(k) K162989

Rusch Simplastic Foley Catheters by Teleflexmedical, Inc. — Product Code EZL

K162989 is an FDA 510(k) premarket notification submitted by Teleflexmedical, Inc. for the device "Rusch Simplastic Foley Catheters". The FDA issued a decision of Substantially Equivalent on February 24, 2017. The device falls under product code EZL (Catheter, Retention Type, Balloon), a Class II device regulated under 21 CFR 876.5130. Teleflexmedical, Inc. has at least 10 other 510(k) clearances on record.