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TACTX MEDICAL, INC.

Last updated May 23, 2026

What TACTX MEDICAL, INC. makes

TACTX Medical, Inc. manufactures coronary angioplasty balloon catheters designed for percutaneous transluminal coronary angioplasty (PTCA) procedures. These devices include variants such as the Empira™ RX and Empira™ NC RX PTCA Dilatation Catheters, which are intended for dilating narrowed coronary arteries during interventional cardiology treatments.

The company’s products fall under FDA Class II devices and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer 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 TACTX Medical, Inc. manufacture?

TACTX Medical, Inc. specializes in coronary angioplasty balloon catheters, specifically designed for percutaneous transluminal coronary angioplasty (PTCA). These devices are used in interventional cardiology to dilate narrowed or blocked coronary arteries, improving blood flow to the heart. The company’s products are primarily focused on this category, ensuring precision and effectiveness in cardiac interventions.

Where is TACTX Medical, Inc. based?

TACTX Medical, Inc. is headquartered in the United States. The company’s location in the US aligns with regulatory frameworks governing medical device manufacturing and distribution in North America, ensuring compliance with local standards and guidelines.

Which regulatory registries or databases list TACTX Medical, Inc.’s devices?

TACTX Medical, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is used to track and identify medical devices authorized for use in the United States, ensuring transparency and traceability in the healthcare system.

How are TACTX Medical, Inc.’s devices classified by regulatory authorities?

TACTX Medical, Inc.’s coronary angioplasty balloon catheters fall under FDA Class II device classification. This classification is assigned based on the level of risk associated with the device, with Class II devices requiring special controls in addition to general controls to ensure their safety and effectiveness.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: US
Address: —
Website: —
LinkedIn: —
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PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 363487070

Catalogue (133)

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Device	Model / Reference	Registries	Class	Status
Empira™ NC RX PTCA Dilatation Catheter	75R06275N	FDA UDI	Class II	Active
Empira™ NC RX PTCA Dilatation Catheter	75R20200N	FDA UDI	Class II	Active
Empira™ RX PTCA Dilatation Catheter	85R30300S	FDA UDI	Class II	Active
Empira™ NC RX PTCA Dilatation Catheter	75R12400N	FDA UDI	Class II	Active
Empira™ RX PTCA Dilatation Catheter	85R30200S	FDA UDI	Class II	Active
Empira™ NC RX PTCA Dilatation Catheter	75R15325N	FDA UDI	Class II	Active
Empira™ RX PTCA Dilatation Catheter	85R12375S	FDA UDI	Class II	Active
Empira™ RX PTCA Dilatation Catheter	85R12350S	FDA UDI	Class II	Active
Empira™ RX PTCA Dilatation Catheter	85R20325S	FDA UDI	Class II	Active
Empira™ RX PTCA Dilatation Catheter	85R20300S	FDA UDI	Class II	Active
Empira™ NC RX PTCA Dilatation Catheter	75R25275N	FDA UDI	Class II	Active
Empira™ RX PTCA Dilatation Catheter	85R30400S	FDA UDI	Class II	Active
Empira™ NC RX PTCA Dilatation Catheter	75R06375N	FDA UDI	Class II	Active
Empira™ NC RX PTCA Dilatation Catheter	75R25200N	FDA UDI	Class II	Active
Empira™ NC RX PTCA Dilatation Catheter	75R06225N	FDA UDI	Class II	Active
Empira™ NC RX PTCA Dilatation Catheter	75R20375N	FDA UDI	Class II	Active
Empira™ RX PTCA Dilatation Catheter	85R30275S	FDA UDI	Class II	Active
Empira™ RX PTCA Dilatation Catheter	85R10200S	FDA UDI	Class II	Active
Empira™ NC RX PTCA Dilatation Catheter	75R06325N	FDA UDI	Class II	Active
Empira™ RX PTCA Dilatation Catheter	85R06400S	FDA UDI	Class II	Active
Empira™ RX PTCA Dilatation Catheter	85R12150S	FDA UDI	Class II	Active
Empira™ RX PTCA Dilatation Catheter	85R15200S	FDA UDI	Class II	Active
Empira™ NC RX PTCA Dilatation Catheter	75R25400N	FDA UDI	Class II	Active
Empira™ RX PTCA Dilatation Catheter	85R06375S	FDA UDI	Class II	Active
Empira™ RX PTCA Dilatation Catheter	85R06150S	FDA UDI	Class II	Active
Empira™ RX PTCA Dilatation Catheter	85R25300S	FDA UDI	Class II	Active
Empira™ NC RX PTCA Dilatation Catheter	75R25250N	FDA UDI	Class II	Active
Empira™ NC RX PTCA Dilatation Catheter	75R15350N	FDA UDI	Class II	Active
Empira™ RX PTCA Dilatation Catheter	85R10275S	FDA UDI	Class II	Active
Empira™ NC RX PTCA Dilatation Catheter	75R30400N	FDA UDI	Class II	Active
Empira™ NC RX PTCA Dilatation Catheter	75R15400N	FDA UDI	Class II	Active
Empira™ NC RX PTCA Dilatation Catheter	75R06300N	FDA UDI	Class II	Active
Empira™ NC RX PTCA Dilatation Catheter	75R10325N	FDA UDI	Class II	Active
Empira™ RX PTCA Dilatation Catheter	85R25350S	FDA UDI	Class II	Active
Empira™ RX PTCA Dilatation Catheter	85R25250S	FDA UDI	Class II	Active
Empira™ NC RX PTCA Dilatation Catheter	75R20350N	FDA UDI	Class II	Active
Empira™ RX PTCA Dilatation Catheter	85R10300S	FDA UDI	Class II	Active
Empira™ NC RX PTCA Dilatation Catheter	75R30325N	FDA UDI	Class II	Active
Empira™ NC RX PTCA Dilatation Catheter	75R20325N	FDA UDI	Class II	Active
Empira™ NC RX PTCA Dilatation Catheter	75R06400N	FDA UDI	Class II	Active
Empira™ RX PTCA Dilatation Catheter	85R10350S	FDA UDI	Class II	Active
Empira™ RX PTCA Dilatation Catheter	85R06350S	FDA UDI	Class II	Active
Empira™ NC RX PTCA Dilatation Catheter	75R20400N	FDA UDI	Class II	Active
Empira™ NC RX PTCA Dilatation Catheter	75R15300N	FDA UDI	Class II	Active
Empira™ NC RX PTCA Dilatation Catheter	75R10275N	FDA UDI	Class II	Active
Empira™ NC RX PTCA Dilatation Catheter	75R06350N	FDA UDI	Class II	Active
Empira™ RX PTCA Dilatation Catheter	85R15150S	FDA UDI	Class II	Active
Empira™ RX PTCA Dilatation Catheter	85R15225S	FDA UDI	Class II	Active
Empira™ NC RX PTCA Dilatation Catheter	75R30300N	FDA UDI	Class II	Active
Empira™ NC RX PTCA Dilatation Catheter	75R12325N	FDA UDI	Class II	Active

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