FDA Registration
Active
🇺🇸 United States
TANDEM DIABETES CARE, INC.
Reg #: 3027327302
·
FEI: 3027327302
·
Expires 2026
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- TANDEM DIABETES CARE, INC.
- Registration Number
- 3027327302
- FEI Number
- 3027327302
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2 Wrigley Ste 100
- City
- Irvine
- State
- CA
- ZIP
- 92618
- Country
- US
Regulatory Submissions
- 510(k) Number
- K251854
Owner / Operator
- Firm Name
- Tandem Diabetes Care, Inc.
- Operator Number
- 10039506
- Address
- 12400 High Bluff Drive
- City
- San Diego
- State
- CA
- Postal Code
- 92130
- Country
- US
- Correspondent
- Mark Tarby
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2025-08-11 |
Proprietary Names
Set, Administration, Intravascular, SteadiSet Infusion Set
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility