Reprocessed Agilis NxT Steerable Introducer— 510(k) K250305
Substantially EquivalentInnovative Health
FDA 510(k) clearance K250305 for Reprocessed Agilis NxT Steerable Introducer, Substantially Equivalent on 2026-01-07. Applicant: Innovative Health.
Clearance details
- Applicant
- Innovative Health
- Product code
- Code PNE
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Scottsdale, AZ, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.