FDA Registration
Active
🇺🇸 United States
AXS Infinity Plus
Reg #: 3008853977
·
FEI: 3008853977
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
2
Classifications
3
Registration Details
- Registration Name
- Stryker Neurovascular
- Registration Number
- 3008853977
- FEI Number
- 3008853977
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 47900 Bayside Parkway
- City
- Fremont
- State
- CA
- ZIP
- 94538
- Country
- US
Regulatory Submissions
- 510(k) Number
- K172468
Owner / Operator
- Firm Name
- STRYKER CORP.
- Operator Number
- 1811755
- Address
- 4100 East Milham Ave.
- City
- Kalamazoo
- State
- MI
- Postal Code
- 49001
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | DTL | Class 2 | Cardiovascular | No | 2018-07-25 |
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2018-07-25 |
| Dilator, Catheter | GCC | Class 1 | General, Plastic Surgery | No | 2018-07-25 |
Proprietary Names
AXS Infinity Plus
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility