FDA Registration
Active
🇺🇸 United States
Stryker Neurovascular
Reg #: 3012931345
·
FEI: 3012931345
·
Expires 2026
Products
9
Proprietary Names
19
Establishment Types
2
Classifications
9
Registration Details
- Registration Name
- Stryker Neurovascular
- Registration Number
- 3012931345
- FEI Number
- 3012931345
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 4870 West 2100 South
- City
- Salt Lake City
- State
- UT
- ZIP
- 84120
- Country
- US
Regulatory Submissions
- 510(k) Number
- K211594
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, Intravascular, Diagnostic | DQO | Class 2 | Cardiovascular | No | 2022-02-04 |
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2022-02-04 |
| Catheter, Percutaneous, Neurovasculature | QJP | Class 2 | Cardiovascular | No | 2022-02-04 |
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2019-06-03 |
| Guide, Wire, Catheter, Neurovasculature | MOF | Class 2 | Cardiovascular | No | 2019-06-03 |
| Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment | POL | Class 2 | Neurology | No | 2020-03-27 |
| Catheter, Thrombus Retriever | NRY | Class 2 | Cardiovascular | No | 2020-03-27 |
| Device, Neurovascular Embolization | HCG | Class 2 | Neurology | No | 2022-01-24 |
| Device, Vascular, For Promoting Embolization | KRD | Class 2 | Cardiovascular | No | 2022-01-24 |
Proprietary Names
Trevo Trak 21 Microcatheter
FlowGate2 Balloon Guide Catheter, 8F
Synchro2 Support Guidewire
Synchro2 Guidewire
Synchro-14 Guidewire
Trevo NXT ProVue Retriever
Broadway 8 Catheter
Merci 8F Balloon Guide Catheter
Merci 9F Balloon Guide Catheter
Synchro-10 Guidewire
Trevo Pro 18 Microcatheter
Synchro SELECT Guidewire
DAC 038 (125cm, 136cm); DAC 044 (115cm, 130cm, 136cm); DAC 057 (115cm, 125cm); DAC 070 (105cm, 120cm);
Echo Intracranial Base Catheter
Trevo XP ProVue Retriever, 6x25mm
Trevo XP ProVue Retriever, 3x20mm Trevo XP ProVue Retriever, 4x20mm
InZone® Detachment System
Trevo XP ProVue Retriever, 4x30mm
Trevo XP ProVue Retriever
Establishment Types
Manufacture Medical Device
Sterilize Medical Device for Another Party (Contract Sterilizer)