510(k) K240957

Catapult Guide Sheath by Contract Medical International, GmbH — Product Code DYB

K240957 is an FDA 510(k) premarket notification submitted by Contract Medical International, GmbH for the device "Catapult Guide Sheath". The FDA issued a decision of Substantially Equivalent on August 14, 2024. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Contract Medical International, GmbH has at least 6 other 510(k) clearances on record.