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Creagh Medical

US

Last updated May 24, 2026

Part of Creagh Medical Ltd

What Creagh Medical makes

Creagh Medical manufactures peripheral angioplasty balloon catheters, including basic dilatation models for treating arterial blockages, as well as vascular microcatheters and nonimplantable catheter introduction sets. Their product line includes devices like the Sublime™ 014 Rx PTA Balloon Dilatation Catheter and the Advance Serenity™ series, designed for radial and peripheral vascular access procedures.

These devices are classified as Class II under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The company operates from the United States, adhering to applicable US regulatory standards for medical devices.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

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US
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Catalogue (432)

Page 3 of 9
DeviceModel / ReferenceRegistriesClassStatus
Sublime™ 014 Rx PTA Balloon Dilatation Catheter SRA-DC14-20080
FDA UDI
Class IIActive
Sublime™ 014 Rx PTA Balloon Dilatation Catheter SRA-DC14-35060
FDA UDI
Class IIActive
Advance Serenity™ 14 SER14-120-20-60
FDA UDI
Class IIActive
Telemark™ Microcatheter SURMC150
FDA UDI
Class IIActive
Advance Serenity™ 18 SER18-120-25-150
FDA UDI
Class IIActive
Advance Serenity™ 18 SER18-150-30-120
FDA UDI
Class IIActive
Biotronik Passeo-35 HP 6/40/75
FDA UDI
Class IIActive
Sublime™ Radial Access Guide Sheath SRA-GS18-5F120
FDA UDI
Class IIActive
Dynamis AV D0402062775
FDA UDI
Class IIUnknown
Advance Serenity™ 14 SER14-150-40-100
FDA UDI
Class IIActive
Dynamis AV D0702062575
FDA UDI
Class IIUnknown
Tersus -14 BTK BTK2080S
FDA UDI
Class IIUnknown
Sublime™ Radial Access Guide Sheath SRA-GS35-6F150
FDA UDI
Class IIActive
Tersus -14 BTK BTK3060S
FDA UDI
Class IIUnknown
Biotronik Passeo-35 HP 8/80/75
FDA UDI
Class IIActive
Advance Serenity™ 18 SER18-150-30-100
FDA UDI
Class IIActive
Elm Hp Pta ELM7100S
FDA UDI
Class IIUnknown
Sublime™ Radial Access 018 RX PTA Dilatation Catheter SRA-DC18-20100
FDA UDI
Class IIActive
Tersus -14 BTK BTK35150S
FDA UDI
Class IIUnknown
Biotronik Passeo-35 HP 8/60/75
FDA UDI
Class IIActive
Sublime™ Radial Access 018 RX PTA Dilatation Catheter SRA-DC18-40020
FDA UDI
Class IIActive
First Choice UHP7542
FDA UDI
Class IIActive
Advance Serenity™ 18 SER18-120-35-120
FDA UDI
Class IIActive
Sublime™ Radial Access 018 RX PTA Dilatation Catheter SRA-DC18-60060
FDA UDI
Class IIActive
Dynamis AV D0502062775
FDA UDI
Class IIUnknown
Biotronik Passeo-35 HP 8/40/75
FDA UDI
Class IIActive
ELM PTA Balloon Dilatation Catheter ELMEX1240L
FDA UDI
Class IIUnknown
Biotronik Passeo-35 HP 9/40/75
FDA UDI
Class IIActive
Advance Serenity™ 18 SER18-150-35-120
FDA UDI
Class IIActive
Advance Serenity™ 14 SER14-120-20-40
FDA UDI
Class IIActive
Sublime™ 014 Rx PTA Balloon Dilatation Catheter SRA-DC14-30020
FDA UDI
Class IIActive
Advance Serenity™ 18 SER18-150-35-40
FDA UDI
Class IIActive
Advance Serenity™ 18 SER18-120-40-40
FDA UDI
Class IIActive
Tersus -14 BTK BTK3520L
FDA UDI
Class IIUnknown
Biotronik Passeo-35 HP 8/40/40
FDA UDI
Class IIActive
Elm Hp Pta ELM1040L
FDA UDI
Class IIUnknown
Advance Serenity™ 14 SER14-150-30-40
FDA UDI
Class IIActive
Tersus -14 BTK BTK2520S
FDA UDI
Class IIUnknown
Sublime™ 014 Rx PTA Balloon Dilatation Catheter SRA-DC14-30100
FDA UDI
Class IIActive
Advance Serenity™ 18 SER18-120-20-40
FDA UDI
Class IIActive
Sublime™ 014 Rx PTA Balloon Dilatation Catheter SRA-DC14-25100
FDA UDI
Class IIActive
Tersus -14 BTK BTK20150S
FDA UDI
Class IIUnknown
Tersus -14 BTK BTK20220S
FDA UDI
Class IIUnknown
Tersus -14 BTK BTK25150S
FDA UDI
Class IIUnknown
Sublime™ Radial Access 018 RX PTA Dilatation Catheter SRA-DC18-35040
FDA UDI
Class IIActive
Advance Serenity™ 18 SER18-150-35-60
FDA UDI
Class IIActive
First Choice UHP7556
FDA UDI
Class IIActive
Dynamis AV D0710062575
FDA UDI
Class IIUnknown
Advance Serenity™ 18 SER18-120-20-80
FDA UDI
Class IIActive
Tersus -14 BTK BTK3560S
FDA UDI
Class IIUnknown

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