FDA Registration
Active
🇺🇸 United States
GALT MEDICAL CORP.
Reg #: 1649395
·
FEI: 3000718472
·
Expires 2026
Products
12
Proprietary Names
20
Establishment Types
4
Classifications
12
Registration Details
- Registration Name
- GALT MEDICAL CORP.
- Registration Number
- 1649395
- FEI Number
- 3000718472
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2220 Merritt Dr
- City
- GARLAND
- State
- TX
- ZIP
- 75041
- Country
- US
Regulatory Submissions
- 510(k) Number
- K112398
Owner / Operator
- Firm Name
- Theragenics Corporation
- Operator Number
- 1037598
- Address
- 5203 BRISTOL INDUSTRIAL WAY, --
- City
- Buford
- State
- GA
- Postal Code
- 30518
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Instruments, Surgical, Cardiovascular | DWS | Class 1 | Cardiovascular | No | 2005-12-30 |
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2012-12-27 |
| Dilator, Vessel, For Percutaneous Catheterization | DRE | Class 2 | Cardiovascular | No | 2020-03-09 |
| Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | DTL | Class 2 | Cardiovascular | No | 2015-12-28 |
| Tourniquet, Nonpneumatic | GAX | Class 1 | General, Plastic Surgery | No | 2024-01-22 |
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 2004-05-12 |
| Needle, Catheter | GCB | Class 1 | General, Plastic Surgery | No | 2012-12-27 |
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2007-11-20 |
| Blade, Scalpel | GES | Class 1 | General, Plastic Surgery | No | 2004-05-12 |
| Percutaneous Sheath Introducer Kit | OFL | Class 2 | Cardiovascular | No | 2021-12-07 |
| Stylet, Catheter | DRB | Class 2 | Cardiovascular | No | 2019-06-06 |
| Accessories, Catheter | KGZ | Class 1 | General, Plastic Surgery | No | 2012-12-27 |
Proprietary Names
GUIDEWIRE INTRODUCER NEEDLE
Valved Tearaway Introducer
Dilator
Coaxial
Syringe
MicroSlide Tearaway Introducer
CATHETER NEEDLE
Nitinol Guidewires (Mandrel)
Blade
GaltStick
Micro-Access Tearaway
Medcomp® BREEZE® AND BREEZE® XS INTRODUCER KIT
Galt Medical Corp. Introducer Kits
GaltTWS
Centeze Drainage Catheter
Galt VTI
QuickTork Guidewire Torque Device (025"-040") (TOR-100-25)
QuickTork Guidewire Torque Device (010"-020") (TOR-100-10)
Elite HV
Galt Medical Guidewire
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device for Another Party (Contract Manufacturer)
Repack or Relabel Medical Device