Euphora™
The FDA filing identifies Euphora as a rapid exchange balloon dilatation catheter in the percutaneous transluminal coronary angioplasty device category. The described device is the Euphora…
The FDA filing identifies Euphora as a rapid exchange balloon dilatation catheter in the percutaneous transluminal coronary angioplasty device category. The described device is the Euphora RX system.
A balloon at the catheter’s distal end is inflated to a defined diameter and pressure. The filing also says its lumen permits a guidewire to position the catheter during use.
Listed Item
Balloon EUP22515X Euphora RX US
Catheter Features
Radiopaque marker bands on the balloon and shaft markers are described as placement features. The filing identifies a proximal female luer for attachment to an inflation device.
12manufacturers in China registered for this device type
64catalogue numbers in this listing
2510(k) clearances naming this product code
1recall
Who Else Makes It
Concentrated in Jiangsu (4), Guangdong (3), Beijing (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Goals Sterilization Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 26 |
| Wuxi Goals Medical Technology Co., Ltd. | Yixing | Jiangsu | Contract manufacturer | 24 |
| Suzhou Prosteri Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 20 |
| Lepu Medical Technology (Beijing) Co., Ltd. | Beijing | Beijing | Manufacturer | 7 |
| Beijing Target Medical Technologies Inc. | Beijing | Beijing | Contract manufacturer | 7 |
| OrbusNeich Medical (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Complaint-file establishment | 5 |
| Brosmed Medical Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
| Dongguan TT Medical, Inc. | Dongguan | Guangdong | Manufacturer | 4 |
| Kossel Medtech (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 4 |
| Shanghai Microport Medical (Group) Co., Ltd. | Shanghai | Shanghai | Specification developer | 1 |
| Sino Medical Sciences Technology Inc. | Tianjin | Tianjin | Manufacturer | 1 |
Record
| Listed by | Medtronic, Inc., United States |
|---|---|
| FDA product code | LOX |
| Device type | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Device class | Class 2 |
| Regulation | 21 CFR 870.5100 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K143480 |
| Record published | 2016-04-11 |
| Record revised | 2019-10-07 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Outer diameter 1.5 to 4 mm; length 6 to 30 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EUP22515X | Outer Diameter 2.25 mm | In distribution |
| EUP37520X | Outer Diameter 3.75 mm | In distribution |
| EUP2025X | Length 25.0 mm | In distribution |
| EUP1515X | Outer Diameter 1.5 mm | In distribution |
| EUP4020X | Length 20.0 mm | In distribution |
| EUP37512X | Outer Diameter 3.75 mm | In distribution |
| EUP27510X | Outer Diameter 2.75 mm | In distribution |
| EUP3030X | Outer Diameter 3.0 mm | In distribution |
| EUP32506X | Length 6.0 mm | In distribution |
| EUP3520X | Length 20.0 mm | In distribution |
| EUP2020X | Length 20.0 mm | In distribution |
| EUP4006X | Length 6.0 mm | In distribution |
| EUP3530X | Length 30.0 mm | In distribution |
| EUP22520X | Length 20.0 mm | In distribution |
| EUP4030X | Outer Diameter 4.0 mm | In distribution |
| EUP27512X | Outer Diameter 2.75 mm | In distribution |
| EUP27506X | Outer Diameter 2.75 mm | In distribution |
| EUP1510X | Outer Diameter 1.5 mm | In distribution |
| EUP3515X | Outer Diameter 3.5 mm | In distribution |
| EUP3020X | Length 20.0 mm | In distribution |
| EUP3006X | Outer Diameter 3.0 mm | In distribution |
| EUP2520X | Length 20.0 mm | In distribution |
| EUP4012X | Outer Diameter 4.0 mm | In distribution |
| EUP32515X | Length 15.0 mm | In distribution |
| EUP2506X | Outer Diameter 2.5 mm | In distribution |
| EUP2030X | Outer Diameter 2.0 mm | In distribution |
| EUP3015X | Length 15.0 mm | In distribution |
| EUP37510X | Length 10.0 mm | In distribution |
| EUP3012X | Outer Diameter 3.0 mm | In distribution |
| EUP2530X | Outer Diameter 2.5 mm | In distribution |
| EUP37525X | Outer Diameter 3.75 mm | In distribution |
| EUP3010X | Length 10.0 mm | In distribution |
| EUP3525X | Length 25.0 mm | In distribution |
| EUP22525X | Length 25.0 mm | In distribution |
| EUP32510X | Outer Diameter 3.25 mm | In distribution |
| EUP22510X | Outer Diameter 2.25 mm | In distribution |
| EUP32520X | Outer Diameter 3.25 mm | In distribution |
| EUP2525X | Length 25.0 mm | In distribution |
| EUP4025X | Outer Diameter 4.0 mm | In distribution |
| EUP22512X | Outer Diameter 2.25 mm | In distribution |
| EUP27525X | Outer Diameter 2.75 mm | In distribution |
| EUP2515X | Outer Diameter 2.5 mm | In distribution |
| EUP2510X | Length 10.0 mm | In distribution |
| EUP3510X | Outer Diameter 3.5 mm | In distribution |
| EUP3506X | Length 6.0 mm | In distribution |
| EUP22506X | Length 6.0 mm | In distribution |
| EUP2006X | Outer Diameter 2.0 mm | In distribution |
| EUP27520X | Outer Diameter 2.75 mm | In distribution |
| EUP2512X | Length 12.0 mm | In distribution |
| EUP1520X | Length 20.0 mm | In distribution |
| EUP2015X | Outer Diameter 2.0 mm | In distribution |
| EUP3512X | Outer Diameter 3.5 mm | In distribution |
| EUP3025X | Length 25.0 mm | In distribution |
| EUP1512X | Outer Diameter 1.5 mm | In distribution |
| EUP4015X | Length 15.0 mm | In distribution |
| EUP1506X | Outer Diameter 1.5 mm | In distribution |
| EUP2012X | Outer Diameter 2.0 mm | In distribution |
| EUP37515X | Outer Diameter 3.75 mm | In distribution |
| EUP27515X | Outer Diameter 2.75 mm | In distribution |
| EUP2010X | Outer Diameter 2.0 mm | In distribution |
| EUP32525X | Length 25.0 mm | In distribution |
| EUP4010X | Length 10.0 mm | In distribution |
| EUP32512X | Outer Diameter 3.25 mm | In distribution |
| EUP37506X | Length 6.0 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| NC Emerge® | Boston Scientific Corporation | 144 |
| Sprinter® Legend | Medtronic, Inc. | 133 |
| NC Quantum Apex™ | Boston Scientific Corporation | 128 |
| Trek | Abbott Vascular | 120 |
| Emerge™ | Boston Scientific Corporation | 119 |
| NC Trek | Abbott Vascular | 118 |
| Apex™ | Boston Scientific Corporation | 116 |
| Maverick²™ | Boston Scientific Corporation | 113 |
| Apollo Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 110 |
| Sprinter® | Medtronic, Inc. | 108 |
| NC Stormer™ OTW | Medtronic, Inc. | 108 |
| Quantum™ Maverick™ | Boston Scientific Corporation | 106 |
Showing 12 of 67. All products under Catheters, Transluminal Coronary Angioplasty, Percutaneous
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K143480 | 2015-04-02 |
| K141090 | 2014-08-15 |
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Medtronic Ireland | 510(k) number | 2019-09-03 | Class II | Under Investigation by firm | Medtronic has determined that some catheters have a slightly higher diameter stylette causing removal difficulties. | 53137 units | |
| Medtronic Ireland | 510(k) number | 2017-07-13 | Class II | Process design | Stylette removal difficulties on the Euphora and Solarice products. | 69,081 (US) | 2020-08-19 |
| Medtronic Ireland | 510(k) number | 2017-07-13 | Class II | Process design | Stylette removal difficulties on the Euphora and Solarice products. | 105,633 (OUS) | 2020-08-19 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2022-06-24 | Class II | Labeling Change Control | Luer has balloon diameter printed as “2.25mmx12mm” instead of the correct diameter, “2.5mmx12mm” as reflected on the product outer packaging. | 84 units |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P020037 | 2003-06-11 | FX MINIRAIL RX PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER | Abbott Vascular |
| P790017 | 2003-03-04 | NC STORMER OVER-THE-WIRE BALLOON DILATATION CATHETER AND NC STORMER ZIPPER MX BALLOON DILATATION CATHETER | Medtronic Ireland |
| P880027 | 2002-06-25 | PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) | Boston Scientific Corporation |
| P860019 | 2000-12-08 | MAXXUM AND NC MAXXUM PTCA CATHETER | Scimed Life Systems, Inc. |
| P880003 | 2000-07-07 | NINJA FX PTCA DILATATION CATHETER | Cordis Corp. |
| P990008 | 1999-09-27 | COOK MBC PTCA BALLOON DILATATION CATHETER | Cook Incorporated |
| P960014 | 1998-10-05 | MAGELLAN-C PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY(PTCA) CATHETERS MODEL C22020,C22520,C23020,& C23520 | Global Therapeutics, Inc. |
| P970052 | 1998-04-08 | LYNX CONTOUR CORONARY BALLOON DILATATION CATHETER(A NEW MODEL OF THE FACT CATHETER). | Endologix LLC |
| P930012 | 1997-05-29 | THE WRAP(PTCA) CATHETER | Progressive Angioplasty Systems, Inc. |
| P910031 | 1996-12-02 | FACT(TM)AND ARC BALLOON CORNARY DILATATION CATHETERS | Abbott Vascular Devices |
| P890048 | 1996-11-26 | USCI(R) PROBE III(TM) BALLOON-ON-A-WIRE(TM) D. SYS | Usci, Div. C.R. Bard, Inc. |
| P890001 | 1996-06-07 | LEOCOR PICO RUNNER(TM) PTCA CATHETER | Leocor, Inc. |
| P850021 | 1995-07-12 | HYBRID (PTCA) CATHETER | Abbott Vascular |
| P940009 | 1994-09-29 | PERCUTANEUS TRANSLUMINAL CORONARY ANGIOPLASTY CATH | Scimed Life Systems, Inc. |
| P890032 | 1992-07-23 | CORDIS ORION STEERABLE PTCA BALLOON CATHETER | Cordis Corp. |
| P880055 | 1991-07-19 | MICROSS-SL(TM) PTCA DILATATION CATHETER | Boston Scientific Corporation |
| P840040 | 1991-01-30 | HEART TRAK PTCA CATHETER | Boston Scientific Corporation |
| P810046 | 1990-10-05 | ACS RX(R) –.014 CORONARY DILATATION CATHETER | Advanced Cardiovascular Systems, Inc. |
| P870021 | 1990-10-04 | PRIME{TM} MODEL 6520, 6525, 6530 AND 6535 | Medtronic, Inc. |
| P880065 | 1990-09-19 | MANSFIELD SCI. AORTIC VALVULOPLASTY CATHETER | Boston Scientific Corporation |
| P870036 | 1989-06-23 | VERSAFLEX BUCHBINDER OMNIFLEX PTCA CATHETER SYSTEM | Medtronics Interventional Vascular |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.