FDA Registration
Active
🇺🇸 United States
Pure Flow
Reg #: 3012470925
·
FEI: 3012470925
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- XTREEM PULSE
- Registration Number
- 3012470925
- FEI Number
- 3012470925
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 353 WEST 29TH STREET
- City
- New York
- State
- NY
- ZIP
- 10001
- Country
- US
Regulatory Submissions
- 510(k) Number
- K173483
Owner / Operator
- Firm Name
- XTREEM PULSE
- Operator Number
- 10057865
- Address
- 353 WEST 29TH STREET
- City
- New York
- State
- NY
- Postal Code
- 10001
- Country
- US
- Correspondent
- Andrew Barile
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Device, Counter-Pulsating, External | DRN | Class 2 | Cardiovascular | No | 2018-06-05 |
Proprietary Names
Pure Flow
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device