510(k) K964112

BERENSTEIN COIL by Target Therapeutics — Product Code KRD

K964112 is an FDA 510(k) premarket notification submitted by Target Therapeutics for the device "BERENSTEIN COIL". The FDA issued a decision of Substantially Equivalent on February 26, 1997. The device falls under product code KRD (Device, Vascular, For Promoting Embolization), a Class II device regulated under 21 CFR 870.3300. Target Therapeutics has at least 10 other 510(k) clearances on record.