NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter— 510(k) K220171

Name: FDA 510(k) clearance K220171
Creator: U.S. Food and Drug Administration
Published: 2022-07-01

Substantially Equivalent

Northeast Scientific, Inc.

FDA 510(k) clearance K220171 for NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter, Substantially Equivalent on 2022-07-01. Applicant: Northeast Scientific, Inc.. Device class: 2.

Clearance details

Applicant: Northeast Scientific, Inc.
Product code: Code QTF
Device class: Class 2
Regulation: 21 CFR 870.4875
Advisory panel: Cardiovascular
Date received: 2022-01-21
Decision date: 2022-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waterbury, CT, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K220171

K-number listed on FDA's recall record

Z-0018-2026 — NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-410-152. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions.Class II·Ongoing·Northeast Scientific Inc.·20250829

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K220171.

Data sourced from openFDA. This site is unofficial and independent of the FDA.