510(k) K961280

SCIMED 6-10 F TRIGUIDE GUIDE CATHETERS 6F,7F,8F,9F & 10F by Scimed Life Systems, Inc. — Product Code DQY

K961280 is an FDA 510(k) premarket notification submitted by Scimed Life Systems, Inc. for the device "SCIMED 6-10 F TRIGUIDE GUIDE CATHETERS 6F,7F,8F,9F & 10F". The FDA issued a decision of Substantially Equivalent on May 15, 1996. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Scimed Life Systems, Inc. has at least 10 other 510(k) clearances on record.