NKO — System, Balloon, Intra-Aortic And Control, Reprocessed Class III
FDA product code NKO covers "System, Balloon, Intra-Aortic And Control, Reprocessed", a Class III medical device regulated under 21 CFR 870.3535. Submissions are reviewed by the Cardiovascular panel.
Classification Details
- Product Code
- NKO
- Device Class
- Class III
- Regulation Number
- 870.3535
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
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).