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Sign in to claim this brandNATEC MEDICAL LTD
US
Last updated May 24, 2026
What NATEC MEDICAL LTD makes
Natec Medical Ltd manufactures over-the-wire (OTW) percutaneous transluminal angioplasty (PTA) balloon catheters for peripheral and coronary arteries. Their portfolio includes catheters sized for 0.014", 0.018", and 0.035" guidewire compatibility, designed for vascular dilation in both lower-extremity and coronary procedures.
The company’s devices are classified as Class II under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. Natec Medical Ltd is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Natec Medical Ltd manufacture?
Natec Medical Ltd specializes in over-the-wire (OTW) percutaneous transluminal angioplasty (PTA) balloon catheters. These devices are primarily used for vascular dilation in both peripheral and coronary arteries. The company’s portfolio includes catheters compatible with guidewires of 0.014", 0.018", and 0.035", catering to a range of interventional procedures.
Where is Natec Medical Ltd based?
Natec Medical Ltd is headquartered in the United States. The company’s location is relevant for regulatory oversight, manufacturing operations, and compliance with U.S. medical device regulations.
How are Natec Medical Ltd’s devices classified under FDA regulations?
Natec Medical Ltd’s PTA balloon catheters fall under Class II classification by the FDA. This classification is typically assigned to devices that pose moderate risk and require special controls to ensure safety and effectiveness, such as pre-market notifications (510(k)) or other regulatory pathways.
Are Natec Medical Ltd’s devices listed in any regulatory registries?
Yes, Natec Medical Ltd’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency in the medical device supply chain, allowing healthcare providers, regulators, and other stakeholders to verify device details, such as manufacturer information and regulatory status.
What is the primary purpose of Natec Medical Ltd’s PTA balloon catheters?
The primary purpose of Natec Medical Ltd’s PTA balloon catheters is to dilate narrowed or blocked blood vessels in both peripheral arteries (e.g., legs) and coronary arteries (e.g., heart). These catheters are designed to be inserted over a guidewire and inflated to restore blood flow, improving circulation and treating conditions like peripheral artery disease (PAD) or coronary artery disease (CAD).
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- natec-medical.com
- —
- —
- [email protected]
- Phone
- +2304663054
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 565545733
Catalogue (1372)
Page 2 of 28| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| FILAO NC PTCA Dilatation Catheter | N022_25-8US | FDA UDI | Class II | Active |
| TAMARIN BLUE PTCA RX Dilatation Catheter | DSC2_00X12US | FDA UDI | Class II | Active |
| Ebony 0.014" PTA Rx Catheter | PC043_50-100US | FDA UDI | Class II | Active |
| Ebony HP PTA OTW 0.035" Catheter | PG074_00-60S | FDA UDI | Class II | Active |
| Ebony 0.018" PTA OTW Catheter | PC064_00-200US | FDA UDI | Class II | Active |
| Victory 0.035" PTA OTW Catheter | VAA039_00-20US | FDA UDI | Class II | Active |
| Victory 0.018" PTA OTW Catheter | VAD062_50-150US | FDA UDI | Class II | Active |
| Amethyst HP PTA OTW 0.035" catheter | PG0807_00-100S | FDA UDI | Class II | Active |
| Amethyst HP PTA OTW 0.035" catheter | PJ0809_00-20S | FDA UDI | Class II | Active |
| Victory HP PTA 0.035" OTW Catheter | VAHG077_00-150S | FDA UDI | Class II | Active |
| Victory HP PTA 0.035" OTW Catheter | VAHH076_00-120S | FDA UDI | Class II | Active |
| Victory 0.018" PTA OTW Catheter | VAC065_00-40US | FDA UDI | Class II | Active |
| Victory HP PTA 0.035" OTW Catheter | VAHI077_00-20S | FDA UDI | Class II | Active |
| Victory 0.035" PTA OTW Catheter | VAC035_00-60US | FDA UDI | Class II | Active |
| Victory 0.014" PTA OTW Catheter | VAC053_00-150US | FDA UDI | Class II | Active |
| Victory 0.035" PTA OTW Catheter | VAB038_00-80US | FDA UDI | Class II | Active |
| Ebony 0.018" PTA OTW Catheter | PC062_50-200US | FDA UDI | Class II | Active |
| TAMARIN BLUE PTCA RX Dilatation Catheter | DSC2_25X12US | FDA UDI | Class II | Active |
| Ebony 0.014" PTA Rx Catheter | PC043_00-15US | FDA UDI | Class II | Active |
| USE® 0.018" PTA OTW Catheter | USE184_00-40A | FDA UDI | Class II | Active |
| Victory 0.035" PTA OTW Catheter | VAC036_00-200US | FDA UDI | Class II | Active |
| Victory HP PTA 0.035" OTW Catheter | VAHG078_00-40S | FDA UDI | Class II | Active |
| FILAO NC PTCA Dilatation Catheter | N022_75-12US | FDA UDI | Class II | Active |
| Victory 0.018" PTA OTW Catheter | VAD063_50-40US | FDA UDI | Class II | Active |
| Ebony 0.014" PTA Rx Catheter | PC044_50-150US | FDA UDI | Class II | Active |
| Victory HP PTA 0.035" OTW Catheter | VAHH078_00-20S | FDA UDI | Class II | Active |
| Ebony 0.014" PTA Rx Catheter | PC047_00-100US | FDA UDI | Class II | Active |
| Victory 0.018" PTA OTW Catheter | VAD065_00-120US | FDA UDI | Class II | Active |
| Ebony HP PTA OTW 0.035" Catheter | PI079_00-60S | FDA UDI | Class II | Active |
| Victory 0.035" PTA OTW Catheter | VAB0312_00-20US | FDA UDI | Class II | Active |
| Ebony HP PTA OTW 0.035" Catheter | PG074_00-20S | FDA UDI | Class II | Active |
| FILAO NC PTCA Dilatation Catheter | N023_75-12US | FDA UDI | Class II | Active |
| USE® 0.018" PTA OTW Catheter | USE182_50-150B | FDA UDI | Class II | Active |
| USE® 0.014" PTA OTW Catheter | USE143_00-60A | FDA UDI | Class II | Active |
| Victory HP PTA 0.035" OTW Catheter | VAHG076_00-100S | FDA UDI | Class II | Active |
| USE® 0.035" PTA OTW Catheter | USE358_00-150A | FDA UDI | Class II | Active |
| USE® 0.018" PTA OTW Catheter | USE182_50-150A | FDA UDI | Class II | Active |
| Victory HP PTA 0.035" OTW Catheter | VAHH074_00-100S | FDA UDI | Class II | Active |
| Victory 0.014" PTA OTW Catheter | VAD053_50-120US | FDA UDI | Class II | Active |
| Ebony 0.014" PTA OTW Catheter | PC052_50-100US | FDA UDI | Class II | Active |
| Victory 0.018" PTA OTW Catheter | VAD064_00-120US | FDA UDI | Class II | Active |
| Victory 0.014" PTA OTW Catheter | VAD053_00-100US | FDA UDI | Class II | Active |
| Ebony HP PTA OTW 0.035" Catheter | PG078_00-40S | FDA UDI | Class II | Active |
| FILAO NC PTCA Dilatation Catheter | N023_25-30US | FDA UDI | Class II | Active |
| USE® 0.018" PTA OTW Catheter | USE182_50-40B | FDA UDI | Class II | Active |
| FILAO NC PTCA Dilatation Catheter | N023_00-15US | FDA UDI | Class II | Active |
| Ebony 0.014" PTA OTW Catheter | PC052_00-60US | FDA UDI | Class II | Active |
| Ebony 0.035" PTA OTW Catheter | PA036_00-40US | FDA UDI | Class II | Active |
| Victory 0.035" PTA OTW Catheter | VAC037_00-120US | FDA UDI | Class II | Active |
| USE® 0.018" PTA OTW Catheter | USE182_50-40A | FDA UDI | Class II | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Natec Medical Ltd Moka · MU FEI 3004415014