510(k) K143252

Galt Tork, 0.010 to 0.020 inches (yellow), Galt Tork, 0.025 to 0.040 inches (orange) by Needle Tech Products, Inc. — Product Code DQX

K143252 is an FDA 510(k) premarket notification submitted by Needle Tech Products, Inc. for the device "Galt Tork, 0.010 to 0.020 inches (yellow), Galt Tork, 0.025 to 0.040 inches (orange)". The FDA issued a decision of Substantially Equivalent on April 23, 2015. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Needle Tech Products, Inc. has at least 2 other 510(k) clearances on record.