Guidewire, Catheter, Reprocessed
FDA product code NKQ · Class II (moderate risk) · 21 CFR 870.1330 · 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
1recalls
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1860-2021 Class I | Angiographic Guidewire Component: Model Number: 107042, 107044, 107447, 110003, 110004…The component part numbers intended for shipment to a third-party, where they are further processed into… | Medtronic Vascular | 05/04/2021Terminated |