FDA product code QTF: Reprocessed Atherectomy Catheter
QTF is the FDA product code for reprocessed atherectomy catheter. It is a Class II device, regulated under 21 CFR 870.4875 and reviewed by the Cardiovascular panel. FDA has cleared 1 510(k) submission under QTF, 1 in the last five years. The average 510(k) review took 161 days (median 161). FDA has posted 8 recalls for QTF devices, 8 initiated in the last five years.
Definition
Reprocessed atherectomy device for peripheral vasculature. Reprocessing validation data for this device type must be included in a 510(k) submission
Classification
| Field | Value |
|---|---|
| Device name | Reprocessed Atherectomy Catheter |
| Device class | Class II |
| Regulation | 21 CFR 870.4875 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
510(k) clearances per year for QTF
| Year | Clearances | Avg. review days |
|---|---|---|
| 2022 | 1 | 161 |
Compare with all 510(k) review times · Search every QTF clearance
Top QTF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Northeast Scientific, Inc. | 1 | 2022-07-01 |
Most recent QTF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K220171 | Northeast Scientific, Inc. | NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter | 2022-07-01 | 161 |
Recalls for QTF devices
8 product recalls in 1 recall events; 8 initiated in the last five years and 8 still open. Most recent: 2025-08-29.
| Year | Recalls |
|---|---|
| 2025 | 8 |
Frequently asked questions
What is FDA product code QTF?
QTF is the FDA product code for reprocessed atherectomy catheter. It is a Class II device, regulated under 21 CFR 870.4875 and reviewed by the Cardiovascular panel.
What device class is QTF?
Class II, regulation 21 CFR 870.4875. Typical premarket route: 510(k).
How long does a 510(k) take for product code QTF?
Across 1 cleared submissions the average was 161 days from receipt to decision (median 161).
Which companies have the most QTF clearances?
Northeast Scientific, Inc. (1).
Have QTF devices been recalled?
Yes: 8 product recalls across 1 recall events; the most recent began 2025-08-29.
Next steps
- Run an FDA pathway report with predicate devices for product code QTF
- Run a recall and safety report across every QTF manufacturer
- Watch product code QTF for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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