FDA Registration
Active
🇳🇱 Netherlands
AXS Catalyst Distal Access Catheter (AXS Catalyst 7)
Reg #: 3008837339
·
FEI: 3008837339
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- STRYKER EMEA Supply Chain Services
- Registration Number
- 3008837339
- FEI Number
- 3008837339
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Frans Maasweg 2
- City
- Venlo Limburg
- Country
- NL
Regulatory Submissions
- 510(k) Number
- K183463
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 | 2019-03-14 |
Proprietary Names
AXS Catalyst Distal Access Catheter (AXS Catalyst 7)
Establishment Types
Export Device to the United States But Perform No Other Operation on Device