510(k) K961992

NEEDLE'S EYE SNARE by Cook Pacemaker Corp. — Product Code DXE

K961992 is an FDA 510(k) premarket notification submitted by Cook Pacemaker Corp. for the device "NEEDLE'S EYE SNARE". The FDA issued a decision of Substantially Equivalent on December 27, 1996. The device falls under product code DXE (Catheter, Embolectomy), a Class II device regulated under 21 CFR 870.5150. Cook Pacemaker Corp. has at least 10 other 510(k) clearances on record.