510(k) K101117

LEV-OR DILATION CATHETER OTW by Baylis Medical Co., Inc. — Product Code DQY

K101117 is an FDA 510(k) premarket notification submitted by Baylis Medical Co., Inc. for the device "LEV-OR DILATION CATHETER OTW". The FDA issued a decision of Substantially Equivalent on July 16, 2010. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Baylis Medical Co., Inc. has at least 10 other 510(k) clearances on record.