QTF
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Reprocessed Atherectomy Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4875
- Medical specialty
- Cardiovascular
- FDA definition
- Reprocessed atherectomy device for peripheral vasculature. Reprocessing validation data for this device type must be included in a 510(k) submission
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter (K220171) | Northeast Scientific, Inc. | 2022-07-01 |
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