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NKR — System, Catheter Control, Reprocessed Class II

FDA Device Classification

FDA product code NKR covers "System, Catheter Control, Reprocessed", a Class II medical device regulated under 21 CFR 870.1290. Submissions are reviewed by the Cardiovascular panel.

Classification Details

Product Code
NKR
Device Class
Class II
Regulation Number
870.1290
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).

FDA data resources