FDA Registration
Active
🇺🇸 United States
Angel® Catheter Accessory Kit
Reg #: 3027260597
·
FEI: 3027260597
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Mermaid Medical A/S (FL Site)
- Registration Number
- 3027260597
- FEI Number
- 3027260597
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 8033 Cooper Creek Blvd Ste 106
- City
- University Park
- State
- FL
- ZIP
- 34201
- Country
- US
Regulatory Submissions
- 510(k) Number
- K160747
Owner / Operator
- Firm Name
- Mermaid Medical
- Operator Number
- 10045264
- Address
- 8033 Cooper Creek Blvd, Unit 106
- City
- University Park
- State
- FL
- Postal Code
- 34201
- Country
- US
- Correspondent
- Matthew Genzman
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Short-Term Intravascular Filter Catheter | PNS | Class 2 | Cardiovascular | No | 2019-11-27 |
Proprietary Names
Angel® Catheter Accessory Kit
Angel® Catheter
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility