Catheter, Angiography, Reprocessed
FDA product code NLI · Class II (moderate risk) · 21 CFR 870.1200 · 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
1recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K231015 | Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic CathetersNLI · Traditional | Innovative Health, LLC | 07/01/2024SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0551-2009 | Cardiac Imaging Catheter Model #'s: ACU08267996 and ACU55790 Intended for intravascular…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | Sterilmed Inc | 08/08/2008Terminated |