K230376

Substantially Equivalent

Reprocessed Agilis NxT Steerable Introducer

Applicant: Innovative Health, LLC
Product code: PNE
Advisory panel: Cardiovascular
Date received: 2023-02-13
Decision date: 2023-08-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Scottsdale, AZ, US

Download summary PDF View on FDA.gov ↗

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