Catheter, Steerable, Reprocessed
FDA product code NKS · Class II (moderate risk) · 21 CFR 870.1280 · Cardiovascular
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).
0510(k) clearances
0PMA approvals
0recalls