AcuNav Volume ICE Catheter
The AcuNav Volume ICE Catheter provides ultrasound views from within the heart and great vessels. It supplies imaging guidance during cardiac catheter procedures in adult or pediatric…
The AcuNav Volume ICE Catheter provides ultrasound views from within the heart and great vessels. It supplies imaging guidance during cardiac catheter procedures in adult or pediatric patients. It is used to visualize anatomy, physiology and devices, with imaging rather than treatment delivery as its role.
The catheter produces real time three dimensional images as well as conventional two dimensional images. Four way steering positions the ultrasound section within the anatomy. It has a 12.5 French profile and 90 centimetres of usable length.
Use Configuration
The catheter is a single use device. It connects to the imaging system through a push and lock connector, allowing the ultrasound images to be displayed during the procedure.
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 | Siemens Medical Solutions USA, Inc., United States |
|---|---|
| FDA product code | OBJ |
| Device type | Catheter, Ultrasound, Intravascular |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1200 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K163478 |
| Record published | 2022-03-04 |
| Record revised | 2025-03-05 (version 4) |
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 | Handling environment humidity 0 to 90 % RH; Handling environment temperature -10 to 50 °C |
| Sizes | Catheter gauge 12.5 Fr |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 11508800 | Catheter Gauge 12.5 Fr | 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 |
|---|---|
| K233270 | 2023-10-28 |
| K212959 | 2021-10-15 |
| K203726 | 2021-01-19 |
| K173618 | 2017-12-19 |
| K170263 | 2017-06-15 |
| K170992 | 2017-06-15 |
| K163478 | 2017-02-09 |
| K081808 | 2008-09-26 |
| K071234 | 2007-06-29 |
| K042593 | 2004-10-15 |
| K033650 | 2004-02-24 |
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 | Closed |
|---|---|---|---|---|
| 2020-05-22 | Class II | Under Investigation by firm | Due to adverse events received by the firm for left atrial perforations and Atrioventricular Node block. | 2021-10-15 |
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.