510(k) K921851

4 SURE TM SUCTION CATHETERS & KITS by Boston Pacific Medical, Inc. — Product Code BSY

K921851 is an FDA 510(k) premarket notification submitted by Boston Pacific Medical, Inc. for the device "4 SURE TM SUCTION CATHETERS & KITS". The FDA issued a decision of Substantially Equivalent (kit) on July 7, 1993. The device falls under product code BSY (Catheters, Suction, Tracheobronchial), a Class I device regulated under 21 CFR 868.6810. Boston Pacific Medical, Inc. has at least 10 other 510(k) clearances on record.