510(k) K003611

PAIN CARE MULTI-PORT CATHETER, MODEL 2000L by Breg, Inc. — Product Code FRN

K003611 is an FDA 510(k) premarket notification submitted by Breg, Inc. for the device "PAIN CARE MULTI-PORT CATHETER, MODEL 2000L". The FDA issued a decision of Substantially Equivalent on December 13, 2000. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Breg, Inc. has at least 10 other 510(k) clearances on record.