Можно и так:
..и анамнестических/исторических/катамнестических данных оценивается как низкий.
Имеются ввиду уже имеющиеся данные об использовании катетеров, опыт прошлых лет.

Вы немного перефразировали текст, там low относится к probability rating, а не к historical predicate data.

на основе клинических данных по данному устройству и истории использования аналогичных, допущенных на рынок, устройств

http://www.medicaldevicesgroup.net/wp-content/uploads/Rob-Pa...
If that’s the case, you might be able to find an old unit, do the testing against the old unit and
demonstrate it’s the same or get a copy of the previous submission for the predicate device and
compare your data to their historical data.
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidanc...
The legally marketed device(s) to which equivalence is drawn is commonly known as the "predicate." Although devices recently cleared under 510(k) are often selected as the predicate to which equivalence is claimed, any legally marketed device may be used as a predicate.
A device is substantially equivalent if, in comparison to a predicate it:

has the same intended use as the predicate; and
has the same technological characteristics as the predicate;
or
has the same intended use as the predicate; and
has different technological characteristics and the information submitted to FDA;
does not raise new questions of safety and effectiveness; and
demonstrates that the device is at least as safe and effective as the legally marketed device.
https://www.google.ru/url?sa=t&rct=j&q=&esrc=s&source=web&cd...
Аналогичное допущенное на рынок устройство называют “Predicate Device”.