510(k) K091366

INSUFLOW DEWHEART by Lexion Medical, LLC — Product Code HIF

K091366 is an FDA 510(k) premarket notification submitted by Lexion Medical, LLC for the device "INSUFLOW DEWHEART". The FDA issued a decision of Substantially Equivalent on September 3, 2009. The device falls under product code HIF (Insufflator, Laparoscopic), a Class II device regulated under 21 CFR 884.1730. Lexion Medical, LLC has at least 10 other 510(k) clearances on record.