510(k) K983162

PERI-GUARD, CV PERI-GUARD, OCU-GUARD, SUPPLE PERI-GUARD, PERI-STRIPS - SLEEVE, PERI-STRIPS-STRIPS, PERI-STRIPS DRY, VASC by Bio-Vascular, Inc. — Product Code FTM

K983162 is an FDA 510(k) premarket notification submitted by Bio-Vascular, Inc. for the device "PERI-GUARD, CV PERI-GUARD, OCU-GUARD, SUPPLE PERI-GUARD, PERI-STRIPS - SLEEVE, PERI-STRIPS-STRIPS, PERI-STRIPS DRY, VASC". The FDA issued a decision of Substantially Equivalent on October 9, 1998. The device falls under product code FTM (Mesh, Surgical), a Class II device regulated under 21 CFR 878.3300. Bio-Vascular, Inc. has at least 10 other 510(k) clearances on record.