NKO

System, Balloon, Intra-Aortic And Control, Reprocessed

Product code

NKO

Device name

System, Balloon, Intra-Aortic And Control, Reprocessed

Device class

Class 3

21 CFR

21 CFR 870.3535

Medical specialty

Cardiovascular

Marketing pathway

PMA

FDA classification definition

Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).

Definition text from the FDA device classification database (U.S. federal government work, public domain).