510(k) K203540

Bridge Occlusion Balloon by Spectranetics, Inc. — Product Code MJN

K203540 is an FDA 510(k) premarket notification submitted by Spectranetics, Inc. for the device "Bridge Occlusion Balloon". The FDA issued a decision of Substantially Equivalent on December 23, 2020. The device falls under product code MJN (Catheter, Intravascular Occluding, Temporary), a Class II device regulated under 21 CFR 870.4450. Spectranetics, Inc. has at least 10 other 510(k) clearances on record.