FDA Registration
Active
🇱🇻 Latvia
2.35 mm OTW B-Laser catheter
Reg #: 3016445722
·
FEI: 3016445722
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- OSMUNDS
- Registration Number
- 3016445722
- FEI Number
- 3016445722
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Siltuma iela 4
- City
- Riga
- Country
- LV
Regulatory Submissions
- 510(k) Number
- K181642
Owner / Operator
- Firm Name
- Osmunds
- Operator Number
- 10056745
- Address
- Siltuma iela 4
- City
- Riga
- State
- LV-RIX
- Postal Code
- LV 1058
- Country
- LV
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Peripheral, Atherectomy | MCW | Class 2 | Cardiovascular | No | 2020-12-01 |
Proprietary Names
2.35 mm OTW B-Laser catheter
1.5 mm OTW B-Laser catheter
2 mm OTW B-Laser catheter
0.9 mm OTW B-Laser catheter
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)