NMM — Catheter, Angioplasty, Peripheral, Transluminal, Reprocessed Class II

FDA Device Classification

FDA product code NMM covers "Catheter, Angioplasty, Peripheral, Transluminal, Reprocessed", a Class II medical device regulated under 21 CFR 870.1250. Submissions are reviewed by the Cardiovascular panel.

Classification Details

Product Code
NMM
Device Class
Class II
Regulation Number
870.1250
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)