NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700)— 510(k) K250592

Substantially Equivalent

Northeast Scientific, Inc.

FDA 510(k) clearance K250592 for NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700), Substantially Equivalent on 2025-05-12. Applicant: Northeast Scientific, Inc..

Clearance details

Applicant: Northeast Scientific, Inc.
Product code: Code OWQ
Advisory panel: Cardiovascular
Date received: 2025-02-27
Decision date: 2025-05-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waterbury, CT, US

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