FDA Registration
Active
🇺🇸 United States
ABLATIVE SOLUTIONS, INC.
Reg #: 3010334444
·
FEI: 3010334444
·
Expires 2026
Products
1
Proprietary Names
2
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- ABLATIVE SOLUTIONS, INC.
- Registration Number
- 3010334444
- FEI Number
- 3010334444
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 301 Edgewater Place, Suite 100
- City
- Wakefield
- State
- MA
- ZIP
- 01880
- Country
- US
Regulatory Submissions
- 510(k) Number
- K231279
Owner / Operator
- Firm Name
- Ablative Solutions, Inc.
- Operator Number
- 10044459
- Address
- 301 Edgewater Place, Suite 100
- City
- Wakefield
- State
- MA
- Postal Code
- 01880
- Country
- US
- Correspondent
- Kristine Canavan
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Continuous Flush | KRA | Class 2 | Cardiovascular | No | 2024-02-01 |
Proprietary Names
Peregrine System(TM) Infusion Catheter
Peregrine System Infusion Catheter
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198
Manufacture Device in the United States for Export Only