FDA Registration
Active
🇺🇸 United States
SafeSharp Transseptal Needle
Reg #: 3013986346
·
FEI: 3013986346
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- PRESSURE PRODUCTS MEDICAL DEVICE MANUFACTURING LLC
- Registration Number
- 3013986346
- FEI Number
- 3013986346
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1 School Street
- City
- Morton
- State
- PA
- ZIP
- 19070
- Country
- US
Regulatory Submissions
- 510(k) Number
- K241042
Owner / Operator
- Firm Name
- Pressure Products Medical Device Manufacturing LLC
- Operator Number
- 10052778
- Address
- 1 School Street
- City
- Morton
- State
- PA
- Postal Code
- 19070
- Country
- US
- Correspondent
- Andrew W Armour
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Trocar | DRC | Class 2 | Cardiovascular | No | 2024-06-03 |
Proprietary Names
SafeSharp Transseptal Needle
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device