QTF · Class II · 21 CFR 870.4875

FDA Product Code QTF: Reprocessed Atherectomy Catheter

Reprocessed Atherectomy Device For Peripheral Vasculature. Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission

Leading manufacturers include Northeast Scientific, Inc..

1
Total
1
Cleared
161d
Avg days
2022
Since
Stable submission activity - 0 submissions in the last 2 years

FDA 510(k) Cleared Reprocessed Atherectomy Catheter Devices (Product Code QTF)

1 devices
1–1 of 1
Cleared Jul 01, 2022
NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter
K220171
Northeast Scientific, Inc.
Cardiovascular · 161d

About Product Code QTF - Regulatory Context

510(k) Submission Activity

1 total 510(k) submissions under product code QTF since 2022, with 1 receiving FDA clearance (average review time: 161 days).

Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.