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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: —
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LinkedIn: —
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PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 363487070

Catalogue (133)

Page 1 of 3

Device	Model / Reference	Registries	Class	Status
Empira™ NC RX PTCA Dilatation Catheter	75R15225N	FDA UDI	Class II	Active
Empira™ RX PTCA Dilatation Catheter	85R20400S	FDA UDI	Class II	Active
Empira™ RX PTCA Dilatation Catheter	85R20250S	FDA UDI	Class II	Active
Empira™ NC RX PTCA Dilatation Catheter	75R10375N	FDA UDI	Class II	Active
Empira™ NC RX PTCA Dilatation Catheter	75R25375N	FDA UDI	Class II	Active
Empira™ RX PTCA Dilatation Catheter	85R25400S	FDA UDI	Class II	Active
Empira™ RX PTCA Dilatation Catheter	85R20375S	FDA UDI	Class II	Active
Empira™ NC RX PTCA Dilatation Catheter	75R10300N	FDA UDI	Class II	Active
Empira™ RX PTCA Dilatation Catheter	85R20275S	FDA UDI	Class II	Active
Empira™ NC RX PTCA Dilatation Catheter	75R25225N	FDA UDI	Class II	Active
Empira™ RX PTCA Dilatation Catheter	85R25150S	FDA UDI	Class II	Active
Empira™ NC RX PTCA Dilatation Catheter	75R25350N	FDA UDI	Class II	Active
Empira™ RX PTCA Dilatation Catheter	85R20200S	FDA UDI	Class II	Active
Empira™ NC RX PTCA Dilatation Catheter	75R12275N	FDA UDI	Class II	Active
Empira™ NC RX PTCA Dilatation Catheter	75R12350N	FDA UDI	Class II	Active
Empira™ RX PTCA Dilatation Catheter	85R12200S	FDA UDI	Class II	Active
Empira™ RX PTCA Dilatation Catheter	85R10150S	FDA UDI	Class II	Active
Empira™ RX PTCA Dilatation Catheter	85R15300S	FDA UDI	Class II	Active
Empira™ NC RX PTCA Dilatation Catheter	75R12300N	FDA UDI	Class II	Active
Empira™ NC RX PTCA Dilatation Catheter	75R20275N	FDA UDI	Class II	Active
Empira™ RX PTCA Dilatation Catheter	85R30375S	FDA UDI	Class II	Active
Empira™ NC RX PTCA Dilatation Catheter	75R30375N	FDA UDI	Class II	Active
Empira™ RX PTCA Dilatation Catheter	85R10225S	FDA UDI	Class II	Active
Empira™ RX PTCA Dilatation Catheter	85R06325S	FDA UDI	Class II	Active
Empira™ RX PTCA Dilatation Catheter	85R30225S	FDA UDI	Class II	Active
Empira™ RX PTCA Dilatation Catheter	85R12250S	FDA UDI	Class II	Active
Empira™ NC RX PTCA Dilatation Catheter	75R20225N	FDA UDI	Class II	Active
Empira™ RX PTCA Dilatation Catheter	85R25200S	FDA UDI	Class II	Active
Empira™ NC RX PTCA Dilatation Catheter	75R15250N	FDA UDI	Class II	Active
Empira™ NC RX PTCA Dilatation Catheter	75R12375N	FDA UDI	Class II	Active
Empira™ NC RX PTCA Dilatation Catheter	75R30275N	FDA UDI	Class II	Active
Empira™ RX PTCA Dilatation Catheter	85R20350S	FDA UDI	Class II	Active
Empira™ RX PTCA Dilatation Catheter	85R30325S	FDA UDI	Class II	Active
Empira™ RX PTCA Dilatation Catheter	85R30250S	FDA UDI	Class II	Active
Empira™ NC RX PTCA Dilatation Catheter	75R15375N	FDA UDI	Class II	Active
Empira™ NC RX PTCA Dilatation Catheter	75R10350N	FDA UDI	Class II	Active
Empira™ NC RX PTCA Dilatation Catheter	75R12250N	FDA UDI	Class II	Active
Empira™ NC RX PTCA Dilatation Catheter	75R12200N	FDA UDI	Class II	Active
Empira™ NC RX PTCA Dilatation Catheter	75R25300N	FDA UDI	Class II	Active
Empira™ RX PTCA Dilatation Catheter	85R30350S	FDA UDI	Class II	Active
Empira™ RX PTCA Dilatation Catheter	85R12300S	FDA UDI	Class II	Active
Empira™ RX PTCA Dilatation Catheter	85R15325S	FDA UDI	Class II	Active
Empira™ NC RX PTCA Dilatation Catheter	75R30225N	FDA UDI	Class II	Active
Empira™ RX PTCA Dilatation Catheter	85R06300S	FDA UDI	Class II	Active
Empira™ RX PTCA Dilatation Catheter	85R12275S	FDA UDI	Class II	Active
Empira™ NC RX PTCA Dilatation Catheter	75R12225N	FDA UDI	Class II	Active
Empira™ RX PTCA Dilatation Catheter	85R12400S	FDA UDI	Class II	Active
Empira™ RX PTCA Dilatation Catheter	85R10400S	FDA UDI	Class II	Active
Empira™ NC RX PTCA Dilatation Catheter	75R10225N	FDA UDI	Class II	Active
Empira™ NC RX PTCA Dilatation Catheter	75R30350N	FDA UDI	Class II	Active

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