SSPC3 Delivery Catheter
The SSPC3 Delivery Catheter provides a percutaneous pathway for introducing catheters and pacing or defibrillator leads. It is supplied with a dilator to support entry into the vasculature…
The SSPC3 Delivery Catheter provides a percutaneous pathway for introducing catheters and pacing or defibrillator leads. It is supplied with a dilator to support entry into the vasculature and is intended for single-patient use.
A proximal haemostatic valve controls the access opening, while a soft, rounded radiopaque tip can be visualised under fluoroscopy. The catheter can be slit after the delivered device is positioned so that it can be removed without withdrawing the lead or catheter.
Delivery Configuration
The subject catheter has a 6.5F inner diameter and an 8F outer diameter. Its dilator is compatible with a 0.035-inch guidewire, and different curves and lengths accommodate anatomy and lead placement.
Who Else Makes It
Concentrated in Shanghai (5), Jiangsu (5), Guangdong (3). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jabil Circuit (Shanghai) Ltd. | Shanghai | Shanghai | Contract manufacturer | 31 |
| Covidien Medical Products (Shanghai) Manufacturing LLC | Shanghai | Shanghai | Contract manufacturer | 8 |
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
| 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 Zenith Vascular Scitech Limited | Suzhou | Jiangsu | Manufacturer | 6 |
| Haolang Technology (Foshan) Limited Corporation | Foshan | Guangdong | Contract manufacturer | 6 |
| OrbusNeich Medical (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Complaint-file establishment | 5 |
| Curatia Medical Limited | Suzhou | Jiangsu | Specification developer | 5 |
| Shanghai Wallaby Medical Technologies Co., Inc. | Shanghai | Shanghai | Contract manufacturer | 5 |
| DK Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 3 |
Showing 12 of 14. All 14 manufacturers in China registered for Catheter, Percutaneous
Record
| Listed by | Centerpoint Systems LLC, United States |
|---|---|
| FDA product code | DQY |
| Device type | Catheter, Percutaneous |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1250 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer |
| 510(k) | K190475 |
| Record published | 2019-08-21 |
| Record revised | 2020-05-28 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Keep dry; Special storage condition: Do not store in direct sunlight |
| Sizes | Catheter working length 40 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9183 | Maximum Compatible Guidewire Outside Diameter: 0.035″ | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Launcher™ | Medtronic, Inc. | 3,805 |
| Sherpa NX Balanced™ | Medtronic, Inc. | 1,523 |
| Arrow | Teleflex Medical LLC | 1,249 |
| Z2 | Medtronic, Inc. | 955 |
| Vista Brite TIP | Cordis Corp. | 789 |
| Mach1™ | Boston Scientific Corporation | 777 |
| Sherpa NX Active | Medtronic, Inc. | 571 |
| Zuma® | Medtronic, Inc. | 569 |
| Convey | Pendracare International B.V. | 532 |
| Taiga | Medtronic, Inc. | 307 |
| RunWay™ | Boston Scientific Corporation | 300 |
| ConcierGE Guiding Excellence™ | Merit Medical Systems, Inc. | 295 |
Showing 12 of 500. All products under Catheter, Percutaneous
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K261766 | 2026-07-29 |
| K262240 | 2026-07-29 |
| K250147 | 2025-08-22 |
| K250828 | 2025-06-27 |
| K250492 | 2025-06-18 |
| K243180 | 2024-12-04 |
| K230363 | 2023-03-09 |
| K210009 | 2021-11-24 |
| K190475 | 2019-06-28 |
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.