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

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..

Clearance details

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

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