FDA Registration
Active
🇺🇸 United States
FlowGate2 Balloon Guide Catheter, 8F
Reg #: 3012931345
·
FEI: 3012931345
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Stryker Neurovascular
- Registration Number
- 3012931345
- FEI Number
- 3012931345
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 4870 West 2100 South
- City
- Salt Lake City
- State
- UT
- ZIP
- 84120
- Country
- US
Regulatory Submissions
- 510(k) Number
- K153729
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 |
|---|---|---|---|---|---|
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2016-02-29 |
Proprietary Names
FlowGate2 Balloon Guide Catheter, 8F
Establishment Types
Manufacture Medical Device