Empira™ NC RX PTCA Dilatation Catheter

FDA UDI

Class II (US FDA UDI)

by Tactx Medical, Inc.

Identity

Trade Name: Empira™ NC RX PTCA Dilatation Catheter FDA UDI
Generic Name: Coronary angioplasty balloon catheter, basic FDA UDI
Device Name: Empira™ NC RX PTCA Dilatation Catheter FDA UDI
Model / Reference: 75R15375N FDA UDI
Description: Empira™ NC RX PTCA Dilatation Catheter FDA UDI

Identifiers

Catalog Number: 75R15375N FDA UDI
Primary DI / UDI-DI: 00812917021043 FDA UDI
FDA Product Code: LOX FDA UDI
GMDN Term: Coronary angioplasty balloon catheter, basic FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.5100 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Length — 15 Millimeter FDA UDI
Outer Diameter — 3.75 Millimeter FDA UDI

Category: Coronary angioplasty balloon catheter, basic

Empira™ NC RX PTCA Dilatation Catheter by Tactx Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Coronary angioplasty balloon catheter, basic.

REBEL™ — Boston Scientific · Class III
SPRINTER® LEGEND — MEDTRONIC, INC. · Class II
NC STORMER® OTW — MEDTRONIC, INC. · Class II
Pantera Pro — Biotronik, Inc. · Class II
SPRINTER LEGEND — MEDTRONIC, INC. · Class II
SPRINTER® LEGEND — MEDTRONIC, INC. · Class II
SPRINTER LEGEND — MEDTRONIC, INC. · Class II
Emerge™ — Boston Scientific · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Tactx Medical, Inc.

Sources (1)

FDA UDI 2de2b422-4933-4ad6-abe3-0989669e4136 35 fields · synced May 30, 2026