FDA Registration
Active
🇺🇸 United States
Zoom 6F Insert Catheters
Reg #: 3027329034
·
FEI: 3027329034
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Cirtec Medical
- Registration Number
- 3027329034
- FEI Number
- 3027329034
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 3301 Leonard Ct.
- City
- Santa Clara
- State
- CA
- ZIP
- 95054
- Country
- US
Regulatory Submissions
- 510(k) Number
- K233975
Owner / Operator
- Firm Name
- Cirtec Medical Corporation
- Operator Number
- 10025422
- Address
- 9200 Xylon Ave N
- City
- Brooklyn Park
- State
- MN
- Postal Code
- 55445
- Country
- US
- Correspondent
- Michael R Schnabel
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Intravascular, Diagnostic | DQO | Class 2 | Cardiovascular | No | 2024-04-17 |
Proprietary Names
Zoom 6F Insert Catheters
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)