Soundstar
SoundStar eco 8F G Catheter
4manufacturers in China registered for this device type
6catalogue numbers in this listing
9510(k) clearances naming this product code
1recall
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Philips Ultrasound (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 5 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Jiangsu Tingsn Technology Co., Ltd. | Nanjing | Jiangsu | Manufacturer | 4 |
| Nanjing Shuangwei Biotechnology Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 1 |
Record
| Listed by | Biosense Webster, Inc., United States |
|---|---|
| FDA product code | OBJ |
| Device type | Catheter, Ultrasound, Intravascular |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1200 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K112050 |
| Record published | 2016-09-16 |
| Record revised | 2026-06-12 (version 10) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | expiry date, serial number |
| Storage | Storage environment temperature -10 to 50 °C; Special storage condition: Do not use if package is opened; Special storage condition: Do not use if package is damaged; Special storage condition: Keep out of direct sunlight; Special storage condition: Keep Dry |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10438577 | In distribution | |
| 10439236 | In distribution | |
| SNDSTR10G | In distribution | |
| SNDSTR10 | In distribution | |
| 10439011 | In distribution | |
| 10439072 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arrow | Teleflex Medical LLC | 27 |
| Acist HDi® HD Ivus System | Acist Medical Systems, Inc. | 8 |
| OptiCross | Boston Scientific Corporation | 4 |
| Busse Hospital Disposables | Robert Busse & Co., Inc. | 4 |
| Acist HDi® System Console | Acist Medical Systems, Inc. | 4 |
| OptiCross™ 6 | Boston Scientific Corporation | 3 |
| 7 Fr PV-Catheter | CD Leycom | 3 |
| NES Reprocessed Visions PV.014P RX Digital Ivus Catheter | North East Scientific Inc | 3 |
| OptiCross™ 6 HD | Boston Scientific Corporation | 2 |
| Acist HDi® Bed Rail Mount | Acist Medical Systems, Inc. | 2 |
| 4 Fr PV Catheter | CD Leycom | 2 |
| Eagle Eye Platinum RX Digital Ivus Catheter | Philips Image Guided Therapy Corporation | 2 |
Showing 12 of 63. All products under Catheter, Ultrasound, Intravascular
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K241540 | 2024-06-28 |
| K240050 | 2024-06-12 |
| K223766 | 2023-02-16 |
| K140318 | 2014-03-12 |
| K112050 | 2011-11-18 |
| K101138 | 2010-06-22 |
| K091352 | 2009-12-04 |
| K092064 | 2009-08-07 |
| K070242 | 2007-05-15 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Biosense Webster, Inc. | 510(k) number | 2015-09-10 | Class II | Device Design | Image disappeared from the cardiac ultrasound system when the CARTO 3 EP Navigation System needed restarting while the patient was experiencing pericardial effusion. Affects the CARTOSOUND Module of the CARTO 3 EP Navigation System when us | 1035 (U.S.) | 2016-05-13 |
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.