510(k) K901336

ASI HEMOSTASIS CATHETER by Advanced Surgical Intervention, Inc. — Product Code GBM

K901336 is an FDA 510(k) premarket notification submitted by Advanced Surgical Intervention, Inc. for the device "ASI HEMOSTASIS CATHETER". The FDA issued a decision of Substantially Equivalent on June 20, 1990. The device falls under product code GBM (Catheter, Urethral), a Class II device regulated under 21 CFR 876.5130. Advanced Surgical Intervention, Inc. has at least 8 other 510(k) clearances on record.