FDA Registration
Active
🇺🇸 United States
XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter
Reg #: 3016948450
·
FEI: 3016948450
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- TRANSIT SCIENTIFIC, LLC
- Registration Number
- 3016948450
- FEI Number
- 3016948450
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2757 S 300 W, Suite E
- City
- Salt Lake City
- State
- UT
- ZIP
- 84115
- Country
- US
Regulatory Submissions
- 510(k) Number
- K221986
Owner / Operator
- Firm Name
- Transit Scientific, LLC
- Operator Number
- 10074833
- Address
- 2757 S 300 W, Suite E
- City
- Salt Lake City
- State
- UT
- Postal Code
- 84115
- Country
- US
- Correspondent
- Kelly Himle
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Percutaneous, Cutting/Scoring | PNO | Class 2 | Cardiovascular | No | 2023-01-05 |
Proprietary Names
XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter
Establishment Types
Repack or Relabel Medical Device