Stratus Infusion Catheter— 510(k) K222185
Substantially EquivalentIntervene, Inc.
FDA 510(k) clearance K222185 for Stratus Infusion Catheter, Substantially Equivalent on 2023-04-13. Applicant: Intervene, Inc.. Device class: 2.
Clearance details
- Applicant
- Intervene, Inc.
- Product code
- Code NPG
- Device class
- Class 2
- Regulation
- 21 CFR 870.1210
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- South San Francisco, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.