QTF — Reprocessed Atherectomy Catheter Class II
FDA product code QTF covers "Reprocessed Atherectomy Catheter", a Class II medical device regulated under 21 CFR 870.4875. Submissions are reviewed by the Cardiovascular panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QTF
- Device Class
- Class II
- Regulation Number
- 870.4875
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Definition
Reprocessed atherectomy device for peripheral vasculature. Reprocessing validation data for this device type must be included in a 510(k) submission
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K220171 | northeast scientific | NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter | July 1, 2022 |