510(k) K050521

EMBRYO TRANSFER CATHETER WITH ACCESSORY STYLET, MODELS 9018, 9023, 9018-S, 9023-S by Inntec, Inc. — Product Code MQF

K050521 is an FDA 510(k) premarket notification submitted by Inntec, Inc. for the device "EMBRYO TRANSFER CATHETER WITH ACCESSORY STYLET, MODELS 9018, 9023, 9018-S, 9023-S". The FDA issued a decision of Substantially Equivalent on May 2, 2005. The device falls under product code MQF (Catheter, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6110. Inntec, Inc. has at least 2 other 510(k) clearances on record.