Requirements treated as met
A medical device shall be treated as meeting the requirements of subparagraph (A)(iv), regardless of whether the device meets the requirement of subclause (I) of such subparagraph, if—
(I)#
the device is described by a category established and in effect under clause (i); or
(II)#
the device is described by a category established and in effect under clause (ii) and an application under section 360e of title 21 has been approved with respect to the device, or the device has been cleared for market under section 360(k) of title 21 , or the device is exempt from the requirements of section 360(k) of title 21 pursuant to subsection ( l ) or (m) of section 360 of title 21 or section 360j(g) of title 21 .