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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 2 of 9
DeviceModel / ReferenceRegistriesClassStatus
Sublime™ Radial Access 018 RX PTA Dilatation Catheter SRA-DC18-30080
FDA UDI
Class IIActive
Advance Serenity™ 14 SER14-120-30-80
FDA UDI
Class IIActive
Sublime™ Radial Access 018 RX PTA Dilatation Catheter SRA-DC18-25220
FDA UDI
Class IIActive
Advance Serenity™ 18 SER18-150-35-220
FDA UDI
Class IIActive
Sublime™ Radial Access Guide Sheath SRA-GS35-5F120
FDA UDI
Class IIActive
Advance Serenity™ 18 SER18-150-25-20
FDA UDI
Class IIActive
Biotronik Passeo-35 HP 4/40/75
FDA UDI
Class IIActive
Elm Hp Pta ELM1240S
FDA UDI
Class IIUnknown
Biotronik Passeo-35 HP 5/20/75
FDA UDI
Class IIActive
Advance Serenity™ 18 SER18-120-30-80
FDA UDI
Class IIActive
Sublime™ 014 Rx PTA Balloon Dilatation Catheter SRA-DC14-30040
FDA UDI
Class IIActive
Advance Serenity™ 14 SER14-150-40-150
FDA UDI
Class IIActive
Dynamis AV D0304062775
FDA UDI
Class IIUnknown
Sublime™ 014 Rx PTA Balloon Dilatation Catheter SRA-DC14-25150
FDA UDI
Class IIActive
Dynamis AV D0706062575
FDA UDI
Class IIUnknown
ELM PTA Balloon Dilatation Catheter ELMEX1640L
FDA UDI
Class IIUnknown
Sublime™ Radial Access 018 RX PTA Dilatation Catheter SRA-DC18-50040
FDA UDI
Class IIActive
Advance Serenity® 18 Hydrophilic PTA Balloon Dilatation Catheter SER18-135-70-220
FDA UDI
Class IIActive
Advance Serenity™ 18 SER18-120-20-120
FDA UDI
Class IIActive
Dynamis AV D0806062375
FDA UDI
Class IIUnknown
Tersus -14 BTK BTK4080L
FDA UDI
Class IIUnknown
Advance Serenity™ 14 SER14-120-30-20
FDA UDI
Class IIActive
Tersus -14 BTK BTK25220S
FDA UDI
Class IIUnknown
Sublime™ 014 Rx PTA Balloon Dilatation Catheter SRA-DC14-20150
FDA UDI
Class IIActive
Biotronik Passeo-35 HP 6/20/75
FDA UDI
Class IIActive
Sublime™ Radial Access 018 RX PTA Dilatation Catheter SRA-DC18-30020
FDA UDI
Class IIActive
Advance Serenity™ 18 SER18-120-40-220
FDA UDI
Class IIActive
Tersus -14 BTK BTK35100L
FDA UDI
Class IIUnknown
Sublime™ Radial Access 018 RX PTA Dilatation Catheter SRA-DC18-50080
FDA UDI
Class IIActive
Advance Serenity™ 18 SER18-120-35-60
FDA UDI
Class IIActive
First Choice UHP7564
FDA UDI
Class IIActive
Advance Serenity™ 14 SER14-120-25-220
FDA UDI
Class IIActive
Tersus -14 BTK BTK25100L
FDA UDI
Class IIUnknown
Advance Serenity™ 14 SER14-150-30-220
FDA UDI
Class IIActive
Elm Hp Pta ELM740L
FDA UDI
Class IIUnknown
Sublime™ Radial Access 018 RX PTA Dilatation Catheter SRA-DC18-40120
FDA UDI
Class IIActive
Biotronik Passeo-35 HP 7/60/75
FDA UDI
Class IIActive
Sublime™ Radial Access 018 RX PTA Dilatation Catheter SRA-DC18-30150
FDA UDI
Class IIActive
Sublime™ Radial Access 018 RX PTA Dilatation Catheter SRA-DC18-30060
FDA UDI
Class IIActive
Advance Serenity™ 18 SER18-150-40-150
FDA UDI
Class IIActive
Advance Serenity™ 14 SER14-120-35-80
FDA UDI
Class IIActive
Sublime™ 014 Rx PTA Balloon Dilatation Catheter SRA-DC14-25080
FDA UDI
Class IIActive
Advance Serenity™ 18 SER18-120-35-220
FDA UDI
Class IIActive
Dynamis AV D1204071875
FDA UDI
Class IIUnknown
Tersus -14 BTK BTK3520S
FDA UDI
Class IIUnknown
Sublime™ Radial Access 018 RX PTA Dilatation Catheter SRA-DC18-50100
FDA UDI
Class IIActive
Advance Serenity™ 14 SER14-120-30-220
FDA UDI
Class IIActive
Sublime™ 014 Rx PTA Balloon Dilatation Catheter SRA-DC14-20040
FDA UDI
Class IIActive
Sublime™ Radial Access 018 RX PTA Dilatation Catheter SRA-DC18-20040
FDA UDI
Class IIActive
Tersus -14 BTK BTK3060L
FDA UDI
Class IIUnknown

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