510(k) K181836

4F Infiniti Angiographic Catheter, 4F & 5F Nylex Angiography Catheters, 4F & 5F Tempo Angiography Catheters by Cordis, A Cardinal Health Company — Product Code DQO

K181836 is an FDA 510(k) premarket notification submitted by Cordis, A Cardinal Health Company for the device "4F Infiniti Angiographic Catheter, 4F & 5F Nylex Angiography Catheters, 4F & 5F Tempo Angiography Catheters". The FDA issued a decision of Substantially Equivalent on Aug 8, 2018. The device falls under product code DQO (Catheter, Intravascular, Diagnostic), a Class II device regulated under 21 CFR 870.1200.