AcuNav Crystal Ultrasound Catheter
The AcuNav Crystal Ultrasound Catheter provides images from within the heart and large vessels during percutaneous cardiac procedures. It visualizes anatomy, physiology and other devices in…
The AcuNav Crystal Ultrasound Catheter provides images from within the heart and large vessels during percutaneous cardiac procedures. It visualizes anatomy, physiology and other devices in adult and pediatric patients. Its role is imaging guidance, with the catheter connected to a tested compatible ultrasound system.
Controls on the handle steer the distal tip in two planes so the operator can orient the imaging plane toward the area of interest. The catheter supports grayscale, motion and Doppler imaging modes. The subject configuration has a 9 French tip and a 90 cm insertable length.
Supply
The catheter is disposable and supplied for single use following ethylene oxide sterilization. It is used only with ultrasound systems for which compatibility has been established.
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) | K233270 |
| Record published | 2025-01-03 |
| Record revised | 2025-03-05 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | expiry date, serial number |
| Storage | Storage environment temperature 5 to 25 °C; Storage environment humidity 0 to 90 % RH |
| Sizes | Catheter gauge 9 Fr |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 11510825 | Catheter Gauge 9 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.