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510(k) K220171

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

K220171 is an FDA 510(k) premarket notification submitted by Northeast Scientific, Inc. for the device "NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter". The FDA issued a decision of Substantially Equivalent on July 1, 2022. The device falls under product code QTF (Reprocessed Atherectomy Catheter), a Class II device regulated under 21 CFR 870.4875. Northeast Scientific, Inc. has at least 5 other 510(k) clearances on record.

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

Other clearances by Northeast Scientific, Inc.

  • K250592 — NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700) (May 12, 2025)
  • K223026 — NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter (February 3, 2023)
  • K200195 — NES Reprocessed Visions PV .014P RX Digital IVUS Catheter (June 22, 2020)
  • K090661 — NES REPROCESSED VARICOSE VEIN RF CATHETER (July 21, 2010)
  • K060676 — NES REPROCESSED ENDOSCOPIC TROCAR (September 7, 2007)

FDA data resources