FDA Registration
Active
🇺🇸 United States
HiPoint reperfusion catheter with Tenzing
Reg #: 3030088112
·
FEI: 3030088112
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Route 92 Medical, West Jordan
- Registration Number
- 3030088112
- FEI Number
- 3030088112
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1375 W 8040 S
- City
- W Jordan
- State
- UT
- ZIP
- 84088
- Country
- US
Regulatory Submissions
- 510(k) Number
- K243601
Owner / Operator
- Firm Name
- Route 92 Medical
- Operator Number
- 10054934
- Address
- 155 Bovet Road, Suite 100
- City
- San Mateo
- State
- CA
- Postal Code
- 94402
- Country
- US
- Correspondent
- Matthew Fortson
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Thrombus Retriever | NRY | Class 2 | Cardiovascular | No | 2025-05-23 |
Proprietary Names
HiPoint reperfusion catheter with Tenzing
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device