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510(k) K220171

NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter by Northeast Scientific, Inc. — Product Code QTF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 2022
Date Received
January 21, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reprocessed Atherectomy Catheter
Device Class
Class II
Regulation Number
870.4875
Review Panel
CV
Submission Type

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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