Fluid Dock
Filling Device
4manufacturers in China registered for this device type
1catalogue number
12510(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 | Boston Scientific Corporation, United States |
|---|---|
| FDA product code | OBJ |
| Device type | Catheter, Ultrasound, Intravascular |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1200 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-09-24 |
| Record revised | 2018-08-09 (version 3) |
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 |
| Packaging | Pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M00499150 | 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 |
| Soundstar | Biosense Webster, Inc. | 6 |
| 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 |
Showing 12 of 63. All products under Catheter, Ultrasound, Intravascular
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K260816 | 2026-04-08 |
| K230453 | 2023-05-18 |
| K222568 | 2022-09-23 |
| K213593 | 2022-01-14 |
| K173820 | 2018-01-17 |
| K173284 | 2017-11-16 |
| K160514 | 2016-06-22 |
| K161125 | 2016-05-19 |
| K153617 | 2016-02-25 |
| K123621 | 2013-04-15 |
| K111043 | 2011-08-04 |
| K051679 | 2005-07-14 |
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 |
|---|---|---|---|---|
| 2024-03-05 | Class II | Process control | Certain batches of Opticross 40MHz Coronary Imaging Catheters manufactured using an incorrect voltage setting, which may have resulted in decreased image brightness. | 239 units |
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.