ComboMap Pressure and Flow System
Catalogue number 6800, listed by Volcano Corporation, United States, under Catheter, Ultrasound, Intravascular. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
1catalogue number
14510(k) clearances naming this product code
10recalls on this code
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 | Volcano Corporation, 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 |
| Record published | 2016-12-08 |
| Record revised | 2022-01-26 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6800 | 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 |
|---|---|
| K160583 | 2016-10-26 |
| K153094 | 2015-12-31 |
| K152829 | 2015-11-19 |
| K150442 | 2015-09-04 |
| K143701 | 2015-08-26 |
| K121273 | 2012-09-10 |
| K120697 | 2012-04-05 |
| K092596 | 2009-12-10 |
| K080891 | 2008-05-12 |
| K073473 | 2008-01-14 |
| K071554 | 2008-01-04 |
| K071660 | 2007-08-31 |
| K051337 | 2005-08-18 |
| K050995 | 2005-06-20 |
Recalls
8 of these are Class II. Class II means a temporary or reversible health consequence. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2025-06-13 | Class II | Reports of IVUS catheter and guide wire entanglement during radial-to-peripheral procedures, due to catheter use without appropriate sheath and/or guide catheter, which may require further intervention, such as surgical removal; Firm is res | 233,817 | ||
| 2022-05-13 | Class III | Process control | Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications | 7,520 units | |
| 2022-05-13 | Class III | Process control | Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications | 14.031 units | |
| 2018-10-17 | Class II | Under Investigation by firm | Visions PV.035 Intravascular Ultrasound (IVUS) Catheters (catalog number 88901 adnd81234) due to the potential inability to pass the guidewire through the y-port of the catheter. | 6870 units | 2021-04-30 |
| 2018-10-17 | Class II | Under Investigation by firm | Visions PV.035 Intravascular Ultrasound (IVUS) Catheters (catalog number 88901 adnd81234) due to the potential inability to pass the guidewire through the y-port of the catheter. | 1240 units | 2021-04-30 |
| 2017-11-03 | Class II | Software design | On certain Impacted Systems, an unexpected Microsoft Windows Security dialog may appear during use, and the users response to the dialog may adversely affect the subsequent operation of the device. | 1166 Units | 2023-10-20 |
| 2017-03-29 | Class II | Under Investigation by firm | High complaint rates of kinking near the junction of the proximal shaft to telescope section of the catheter. Kinking could result in disruption of normal clinical workflow or loss of imaging. | 718 total devices | 2017-06-21 |
| 2017-03-29 | Class II | Under Investigation by firm | High complaint rates of kinking near the junction of the proximal shaft to telescope section of the catheter. Kinking could result in disruption of normal clinical workflow or loss of imaging. | 718 total units | 2017-06-21 |
| 2016-04-25 | Class II | Software in the Use Environment | Volcano has become aware of an incompatibility issue between Impacted Systems and hospital network scans. In specific circumstances, an impacted System will encounter unexpected data from the hospital network and be forced to reboot | 5875 (2685 in US; 3190 ROW) | 2018-01-02 |
| 2015-06-04 | Class II | Labeling mix-ups | During a relabeling procedure at the manufacturing facility, the products were labeled with a shelf life in accordance with the date of the relabeling and not in accordance with the original shelf life date at the time of manufacture | 162 total devices (included both products) | 2015-10-27 |
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.