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Reprocessed Atherectomy Catheter

FDA product code QTF · 1 cleared devices

Class 2 Cardiovascular
Regulation
21 CFR 870.4875
Review panel
CV
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2022-07-01 – 2022-07-01

Reprocessed atherectomy device for peripheral vasculature. Reprocessing validation data for this device type must be included in a 510(k) submission

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