DeviceClearance

NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter— 510(k) K223026

Substantially Equivalent

Northeast Scientific, Inc.

FDA 510(k) clearance K223026 for NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter, Substantially Equivalent on 2023-02-03. Applicant: Northeast Scientific, Inc..

Clearance details

Applicant
Northeast Scientific, Inc.
Product code
Code OWQ
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Waterbury, CT, US
Download summary PDFView on FDA.gov ↗

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