Solopath
SOLOPATH Balloon Expandable TransFemoral System
13manufacturers in China registered for this device type
18catalogue numbers in this listing
5510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (5), Beijing (3), Shanghai (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Mehow Innovative (Huizhou) Ltd. | Huizhou | Guangdong | Contract manufacturer | 11 |
| Tianjin Demax Medical Technology Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 5 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Shanghai INT Medical Instruments Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Lepu Medical Technology (Beijing) Co., Ltd. | Beijing | Beijing | Manufacturer | 7 |
| Beijing Target Medical Technologies Inc. | Beijing | Beijing | Contract manufacturer | 7 |
| Beijing Demax Medical Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 5 |
| Curatia Medical Limited | Suzhou | Jiangsu | Specification developer | 5 |
| Tianjin Ethylene Oxide Sterilization Technology Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 4 |
| Shanghai Microport EP Medtech Co., Ltd. | Shanghai | Shanghai | Manufacturer | 3 |
| Becton Dickinson Medical Devices Co., Ltd. Suzhou | Suzhou | Jiangsu | Contract manufacturer | 2 |
| Cardiocycle Medical(Suzhou) Co., Ltd. | Suzhou | Jiangsu | Complaint-file establishment | 1 |
Showing 12 of 13. All 13 manufacturers in China registered for Introducer, Catheter
Record
| Listed by | Onset Medical Corporation, United States |
|---|---|
| FDA product code | DYB |
| Device type | Introducer, Catheter |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1340 |
| Record published | 2016-09-24 |
| Record revised | 2024-03-20 (version 5) |
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, expiry date |
| Storage | Special storage condition: Avoid direct sunlight; Special storage condition: Do not store at extreme temperature and humidity; Storage environment humidity up to 80 % RH; Storage environment temperature 15 to 30 °C |
| Packaging | Carton of 39 |
| Sizes | Length 25 to 35 cm |
| Distribution end date | 2019-10-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| STFI-2125 | Maximum Rated Inflation Pressure: 20 atm/bar or 2026 kPa or 294 psi | Withdrawn |
| STFI-1625 | Maximum Rated Inflation Pressure: 20 atm/bar or 2026 kPa or 294 psi | Withdrawn |
| SR-2225 | Outer Diameter: 26 French | Withdrawn |
| SR-2025 | Nominal Inflation Pressure: 20 atm/bar or 2026 kPa or 294 psi | Withdrawn |
| STFI-1825 | Maximum Rated Inflation Pressure: 20 atm/bar or 2026 kPa or 294 psi | Withdrawn |
| SR-1925 | Outer Diameter: 23 French | Withdrawn |
| SR-2035 | Nominal Inflation Pressure: 20 atm/bar or 2026 kPa or 294 psi | Withdrawn |
| SR-2235 | Length 35 cm | Withdrawn |
| STFI-1925 | Length 25 cm | Withdrawn |
| SR-2425 | Outer Diameter: 28.5 French | Withdrawn |
| STFI-2135 | Maximum Rated Inflation Pressure: 20 atm/bar or 2026 kPa or 294 psi | Withdrawn |
| STFI-1935 | Outer Diameter: 22 French | Withdrawn |
| SR-2435 | Length 35 cm | Withdrawn |
| STFI-1435 | Length 35 cm | Withdrawn |
| STFI-1635 | Inner Diameter: 16 French | Withdrawn |
| STFI-1835 | Inner Diameter: 18 French | Withdrawn |
| SR-1935 | Outer Diameter: 23 French | Withdrawn |
| STFI-1425 | Inner Diameter: 14 French | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Demax | Beijing Demax Medical Technology Co., Ltd. | 2,841 |
| Arrow | Teleflex Medical LLC | 1,036 |
| Prelude IDeal™ | Merit Medical Systems, Inc. | 294 |
| Fast-Cath™ | St. Jude Medical | 213 |
| Flexor | Cook Incorporated | 182 |
| Prelude Ease™ | Merit Medical Systems, Inc. | 176 |
| Performer | Cook Incorporated | 174 |
| VSI | Teleflex Medical LLC | 154 |
| Peel-Away | Cook Incorporated | 153 |
| OptiSeal™ | Greatbatch Medical | 127 |
| Brilliant | Lepu Medical Technology (Beijing) Co., Ltd. | 122 |
| Super Sheath | Togo Medikit Co., Ltd. | 122 |
Showing 12 of 439. All products under Introducer, Catheter
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K152498 | 2016-01-05 |
| K121404 | 2013-05-03 |
| K100819 | 2010-08-02 |
| K092014 | 2009-10-08 |
| K062852 | 2007-02-23 |
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.