AcQMap
Adapter Cable-Short, Ablation Adapter to AcQMap
10manufacturers in China registered for this device type
38catalogue numbers in this listing
12510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (7), Shanghai (2), Jiangsu (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Jabil Circuit (Shanghai) Ltd. | Shanghai | Shanghai | Contract manufacturer | 31 |
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Dongguan Ergotron Precision Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 2 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Shenzhen BelterHealthMeasurementAndAnalysisTechnologyCo.,Ltd | Shenzhen | Guangdong | Manufacturer | 7 |
| Philips (China) Investment Co., Ltd. Philips Healthcare – Shanghai CDC | Shanghai | Shanghai | Specification developer | 6 |
| Shenzhen Carewell Electronics Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 2 |
Record
| Listed by | Acutus Medical, Inc., United States |
|---|---|
| FDA product code | DQK |
| Device type | Computer, Diagnostic, Programmable |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1425 |
| Record published | 2018-02-15 |
| Record revised | 2024-11-15 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Distribution end date | 2023-11-08 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 800109 | Withdrawn | |
| 800405 | Withdrawn | |
| 800748 | Withdrawn | |
| 800523 | Withdrawn | |
| 800431 | Withdrawn | |
| 800697 | Withdrawn | |
| 900100 | Withdrawn | |
| 800745 | Withdrawn | |
| 800522 | Withdrawn | |
| 800520 | Withdrawn | |
| 800500 | Withdrawn | |
| 800739 | Withdrawn | |
| 800426 | Withdrawn | |
| 800229 | Withdrawn | |
| 800255 | Withdrawn | |
| 800258 | Withdrawn | |
| 800407 | Withdrawn | |
| 800698 | Withdrawn | |
| 800531 | Withdrawn | |
| 800508 | Withdrawn | |
| 800505 | Withdrawn | |
| 800244-001 | Withdrawn | |
| 800696 | Withdrawn | |
| 800695 | Withdrawn | |
| 800601 | Withdrawn | |
| 800430 | Withdrawn | |
| 800112 | Withdrawn | |
| 800424 | Withdrawn | |
| 800742 | Withdrawn | |
| 800604 | Withdrawn | |
| 900000 | Withdrawn | |
| 800422 | Withdrawn | |
| 800113 | Withdrawn | |
| 800421 | Withdrawn | |
| 800605 | Withdrawn | |
| 800524 | Withdrawn | |
| 800254 | Withdrawn | |
| 800710 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| EnSite™ | St. Jude Medical | 177 |
| Computer, Diagnostic, Programmable | St. Jude Medical | 57 |
| MediGuide™ | St. Jude Medical | 41 |
| WorkMate Claris™ | St. Jude Medical | 35 |
| iLab Ultrasound Imaging System | Boston Scientific Corporation | 32 |
| Rhythmia™ Mapping System | Boston Scientific Corporation | 31 |
| Sentinel | Spacelabs Healthcare (Washington), Inc | 28 |
| Rhythmia HDx™ | Boston Scientific Corporation | 26 |
| EnSite Precision™ | St. Jude Medical | 23 |
| PathfinderSL | Spacelabs Healthcare (Washington), Inc | 22 |
| Labsystem™ PRO | Boston Scientific Corporation | 19 |
| Pathfinder SL | Spacelabs Healthcare (Washington), Inc | 16 |
Showing 12 of 228. All products under Computer, Diagnostic, Programmable
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K231091 | 2023-07-10 |
| K230606 | 2023-05-02 |
| K222209 | 2022-10-17 |
| K220784 | 2022-07-01 |
| K212345 | 2021-08-27 |
| K210680 | 2021-08-05 |
| K201015 | 2020-12-01 |
| K193013 | 2020-02-11 |
| K191392 | 2019-09-06 |
| K190131 | 2019-04-02 |
| K181577 | 2019-02-07 |
| K170948 | 2017-10-16 |
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.