510(k) K053208

CLEAR VISION EMBRYO TRANSFER CATHETER SET, MODEL B100000 - B 100007; CLEAR VISION TRIAL TRANSFER CATHETER SET by Swemed Lab International AB — Product Code MQF

K053208 is an FDA 510(k) premarket notification submitted by Swemed Lab International AB for the device "CLEAR VISION EMBRYO TRANSFER CATHETER SET, MODEL B100000 - B 100007; CLEAR VISION TRIAL TRANSFER CATHETER SET". The FDA issued a decision of Substantially Equivalent on January 30, 2006. The device falls under product code MQF (Catheter, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6110. Swemed Lab International AB has at least 3 other 510(k) clearances on record.