FDA Registration
Active
🇺🇸 United States
AMS350 - MAGELLAN® BASIC ONE SOURCE KIT
Reg #: 3006788678
·
FEI: 3006788678
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Arteriocyte Medical Systems, Inc.
- Registration Number
- 3006788678
- FEI Number
- 3006788678
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 45 South Street
- City
- Hopkinton
- State
- MA
- ZIP
- 01748
- Country
- US
Regulatory Submissions
- 510(k) Number
- K041830
Owner / Operator
- Firm Name
- Arteriocyte Medical Systems, Inc.
- Operator Number
- 10023471
- Address
- 45 South Street
- City
- Hopkinton
- State
- MA
- Postal Code
- 01748
- Country
- US
- Correspondent
- Neil Kizer
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2007-11-26 |
Proprietary Names
AMS350 - MAGELLAN® BASIC ONE SOURCE KIT
AMS505 - MAGELLAN® Ratio Dispenser Kit
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device