FDA Registration
Active
🇨🇦 Canada
SafeSheath CSG Introducer Sheath Kit , Worley Advanced CSG , Worley Advanced LVI Lateral Vein Introducers, et al.
Reg #: 3012536737
·
FEI: 3012536737
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Merit Medical Canada Ltd.
- Registration Number
- 3012536737
- FEI Number
- 3012536737
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1 Valleywood Drive, units 4&5
- City
- Markham Ontario
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K120158
Owner / Operator
- Firm Name
- Merit Medical Systems, Inc.
- Operator Number
- 1721504
- Address
- 1600 West Merit Parkway, --
- City
- South Jordan
- State
- UT
- Postal Code
- 84095
- Country
- US
US Agent
- Business Name
- MERIT MEDICAL SYSTEMS, INC.
- Contact Name
- John Knorpp
- Address
- 1600 West Merit Parkway, --
- City
- South Jordan
- State
- UT
- ZIP
- 84095
- Country
- US
- [email protected]
- Phone
- 801 2084389
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2013-11-21 |
Proprietary Names
SafeSheath CSG Introducer Sheath Kit , Worley Advanced CSG , Worley Advanced LVI Lateral Vein Introducers, et al.
Establishment Types
Export Device to the United States But Perform No Other Operation on Device