Trocar, Reprocessed
FDA product code NMK · Class II (moderate risk) · 21 CFR 870.1390 · 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).
1510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K192998 | Reprocessed BRK Transseptal NeedleNMK · Traditional | Innovative Health, LLC | 07/22/2020SE |