FDA Registration
Inactive
🇺🇸 United States
CULTIV8 1, LLC
·
Expires 2026
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- CULTIV8 1, LLC
- Status
- Inactive
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3405 Annapolis Ln N Ste 200
- City
- Minneapolis
- State
- MN
- ZIP
- 55447
- Country
- US
Regulatory Submissions
- 510(k) Number
- K253652
Owner / Operator
- Firm Name
- Cultiv8 1, LLC
- Operator Number
- 10095946
- Address
- 3405 Annapolis Ln N, Suite 200
- City
- Minneapolis
- State
- MN
- Postal Code
- 55447
- Country
- US
- Correspondent
- Bob Atkinson
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2026-05-27 |
Proprietary Names
Genie MAX
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility