FDA Registration
Active
🇺🇸 United States
XenoSure Biologic Patch
Reg #: 1220948
·
FEI: 1220948
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- LEMAITRE VASCULAR, INC.
- Registration Number
- 1220948
- FEI Number
- 1220948
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 63 SECOND AVENUE
- City
- BURLINGTON
- State
- MA
- ZIP
- 01803
- Country
- US
Regulatory Submissions
- 510(k) Number
- K190882
Owner / Operator
- Firm Name
- LEMAITRE VASCULAR, INC.
- Operator Number
- 1220948
- Address
- 32 Third Ave, --
- City
- Burlington
- State
- MA
- Postal Code
- 01803
- Country
- US
- Correspondent
- Xiang Zhang
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mesh, Surgical | FTM | Class 2 | General, Plastic Surgery | No | 2022-05-03 |
| Vessel Guard Or Cover, To Facilitate Revision Surgeries | MFX | Class 2 | Cardiovascular | No | 2022-05-03 |
| Intracardiac Patch Or Pledget, Biologically Derived | PSQ | Class 2 | Cardiovascular | No | 2022-05-03 |
Proprietary Names
XenoSure Biologic Patch
Establishment Types
Manufacture Medical Device