FDA Registration
Inactive
🇺🇸 United States
CardiaMend
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- HELIOS BIOMEDICAL INC.
- Status
- Inactive
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 33 Strathmore Rd
- City
- Natick
- State
- MA
- ZIP
- 01760
- Country
- US
Regulatory Submissions
- 510(k) Number
- K210331
Owner / Operator
- Firm Name
- Helios Biomedical Inc.
- Operator Number
- 10086401
- Address
- 8 Mercer Rd
- City
- Natick
- State
- MA
- Postal Code
- 01760
- Country
- US
- Correspondent
- Susan Reilly
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Intracardiac Patch Or Pledget, Biologically Derived | PSQ | Class 2 | Cardiovascular | No | 2022-11-07 |
Proprietary Names
CardiaMend
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)