510(k) K021219

SMARTWIRE/SMARTMAP PRESSURE SYSTEM by Jomed, Inc. — Product Code DQX

K021219 is an FDA 510(k) premarket notification submitted by Jomed, Inc. for the device "SMARTWIRE/SMARTMAP PRESSURE SYSTEM". The FDA issued a decision of Substantially Equivalent on May 17, 2002. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Jomed, Inc. has at least 8 other 510(k) clearances on record.