Reprocessed Atherectomy Catheter
The Reprocessed Atherectomy Catheter is a peripheral vascular atherectomy catheter that has been reprocessed from a previously used single-use device to restore it for safe reuse, with reprocessing validation data required as part of its 510(k) submission. It is used to remove atherosclerotic plaque from peripheral blood vessels. Classified as FDA Class 2 under regulation 870.4875, it requires 510(k) clearance in the Cardiovascular specialty. The device is not an implant and not life-sustaining.
Research product code QTF in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- QTF
- Device Class
- FDA class 2
- Regulation Number
- 870.4875
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
Definition
Reprocessed atherectomy device for peripheral vasculature. Reprocessing validation data for this device type must be included in a 510(k) submission
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K220171 | NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter | Jul 01, 2022 | Substantially Equivalent | Northeast Scientific, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.