510(k) K243757

Shockwave CS Guide Catheter by Shockwave Medical, Inc. — Product Code DQY

K243757 is an FDA 510(k) premarket notification submitted by Shockwave Medical, Inc. for the device "Shockwave CS Guide Catheter". The FDA issued a decision of Substantially Equivalent on May 2, 2025. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Shockwave Medical, Inc. has at least 10 other 510(k) clearances on record.