FDA Registration
Inactive
🇺🇸 United States
INTERVENTION TECH, INC
·
Expires 2026
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- INTERVENTION TECH, INC
- Status
- Inactive
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2201 N Gemini Dr, Suite 138
- City
- Flagstaff
- State
- AZ
- ZIP
- 86001
- Country
- US
Regulatory Submissions
- 510(k) Number
- K253855
Owner / Operator
- Firm Name
- Intervention Tech, Inc
- Operator Number
- 10095938
- Address
- 2201 N Gemini Dr, Suite 138
- City
- Flagstaff
- State
- AZ
- Postal Code
- 86001
- Country
- US
- Correspondent
- Michael Franklin
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Balloon Aortic Valvuloplasty | OZT | Class 2 | Cardiovascular | No | 2026-05-26 |
Proprietary Names
KardiaPSI
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility