Cleared Traditional

NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter

K220171 · Northeast Scientific, Inc. · Cardiovascular
Jul 2022
Decision
161d
Days
Class 2
Risk

About This 510(k) Submission

K220171 is an FDA 510(k) clearance for the NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter, a Reprocessed Atherectomy Catheter (Class II — Special Controls, product code QTF), submitted by Northeast Scientific, Inc. (Waterbury, US). The FDA issued a Cleared decision on July 1, 2022, 161 days after receiving the submission on January 21, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4875.

Submission Details

510(k) Number K220171 FDA.gov
FDA Decision Cleared SESE
Date Received January 21, 2022
Decision Date July 01, 2022
Days to Decision 161 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code QTF — Reprocessed Atherectomy Catheter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4875
Definition Reprocessed Atherectomy Device For Peripheral Vasculature. Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission