510(k) K903606

GUIDEWIRE TORQUE DEVICE AND GUIDEWIRE INTRODUCER by North American Instrument Corp. — Product Code LIT

K903606 is an FDA 510(k) premarket notification submitted by North American Instrument Corp. for the device "GUIDEWIRE TORQUE DEVICE AND GUIDEWIRE INTRODUCER". The FDA issued a decision of Substantially Equivalent on September 27, 1990. The device falls under product code LIT (Catheter, Angioplasty, Peripheral, Transluminal), a Class II device regulated under 21 CFR 870.1250. North American Instrument Corp. has at least 10 other 510(k) clearances on record.