510(k) K771048

CATHETERS, DRAINAGE by Axiom Medical, Inc. — Product Code FEG

K771048 is an FDA 510(k) premarket notification submitted by Axiom Medical, Inc. for the device "CATHETERS, DRAINAGE". The FDA issued a decision of Substantially Equivalent on July 19, 1977. The device falls under product code FEG (Tube, Double Lumen For Intestinal Decompression And/Or Intubation), a Class II device regulated under 21 CFR 876.5980. Axiom Medical, Inc. has at least 10 other 510(k) clearances on record.