510(k) K823752

EXTRACORPOREAL SUBCLAVIAN CATHETER KIT by Extracorporeal Medical Specialities, Inc. — Product Code FIQ

K823752 is an FDA 510(k) premarket notification submitted by Extracorporeal Medical Specialities, Inc. for the device "EXTRACORPOREAL SUBCLAVIAN CATHETER KIT". The FDA issued a decision of Substantially Equivalent on January 14, 1983. The device falls under product code FIQ (Cannula, A-V Shunt), a Class II device regulated under 21 CFR 876.5540. Extracorporeal Medical Specialities, Inc. has at least 10 other 510(k) clearances on record.