SoloPace Fusion Kit
The listed SOLOFUSE1 corresponds to the FDA-named Solo Pace Fusion System. The system introduces and positions interventional devices within the heart chambers, including devices used for…
The listed SOLOFUSE1 corresponds to the FDA-named Solo Pace Fusion System. The system introduces and positions interventional devices within the heart chambers, including devices used for transcatheter aortic valve procedures, and can also provide temporary intracardiac pacing.
The kit components include a Fusion Guidewire, ground pad, connection cable and Solo Pace Remote Control Module. The External Pulse Generator is sold separately. FDA describes the guidewire as both a delivery path for interventional devices and a pacing conduit when used with Solo Pace Control.
System Components
The FDA comparison lists a 275 cm guidewire with a stainless-steel shaft, 0.035 inch compatibility and single-use configuration. Temporary pacing transmits an electrical signal from Solo Pace Control to the heart. These functions and components belong to the named Fusion System.
Who Else Makes It
Concentrated in Beijing (4), Jiangsu (3), Guangdong (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Mehow Innovative (Huizhou) Ltd. | Huizhou | Guangdong | Contract manufacturer | 11 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Suzhou Prosteri Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 20 |
| Sunny Medical Device (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
| Lepu Medical Technology (Beijing) Co., Ltd. | Beijing | Beijing | Manufacturer | 7 |
| Beijing Target Medical Technologies Inc. | Beijing | Beijing | Contract manufacturer | 7 |
| Suzhou Zenith Vascular Scitech Limited | Suzhou | Jiangsu | Manufacturer | 6 |
| Beijing Bywave Sensing Medical Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 2 |
| Shanghai Achieva Medical Suzhou Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 2 |
| Deepintec Scientific Co., Ltd. | Beijing | Beijing | Manufacturer | 2 |
Record
| Listed by | Solo Pace Inc, United States |
|---|---|
| FDA product code | DQX |
| Device type | Wire, Guide, Catheter |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1330 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K252674 |
| Record published | 2026-02-05 |
| Record revised | 2026-03-05 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SOLOFUSE1 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arrow | Teleflex Medical LLC | 625 |
| Cook | Cook Incorporated | 410 |
| Guidewire | Argon Medical Devices, Inc. | 173 |
| Medline Industries, Inc. | Medline Industries, Inc. | 151 |
| Guidewire | Galt Medical Corp. | 144 |
| Amplatz | Cook Incorporated | 128 |
| InQwire® | Merit Medical Systems, Inc. | 120 |
| Angiographic Guide Wire | Medtronic, Inc. | 94 |
| Glidewire | Terumo Corp. | 83 |
| Starter™ Guidewire | Lake Region Medical Limited | 82 |
| INT,Falcon Guide Wire | Shanghai Kindly Medical Instruments Co., Ltd. | 72 |
| GuideRight™ | St. Jude Medical | 69 |
Showing 12 of 525. All products under Wire, Guide, Catheter
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K252674 | 2026-01-09 |
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.