Core M2 Vascular System
Catalogue number 400-0100.17, listed by Volcano Corporation, United States, under Cable, Transducer And Electrode, Patient, (Including Connector). 22 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Guangdong (18), Jiangsu (1), Zhejiang (1). 10 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 |
| Ningbo Xinwell Medical Technology Co., Ltd. | Cixi | Zhejiang | Contract manufacturer | 12 |
| APK Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
| ABA Medical Technology Co Ltd | Guang Dong | Guangdong | Contract manufacturer | 6 |
| Beijing Rongrui Century Science Technology Co., Ltd. | Beijing | Beijing | Contract manufacturer | 4 |
| Dongguan Rongrui-Century Science&Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
| Dongguan Ruibaolian Medical Science & Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
| Dongguan Kepler Special Cabling Company Limited | Dongguan | Guangdong | Contract manufacturer | 3 |
| Palconn Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 2 |
| Shenzhen Redy-MED Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 2 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
Showing 12 of 22. All 22 manufacturers in China registered for Cable, Transducer And Electrode, Patient, (Including Connector)
Record
| Listed by | Volcano Corporation, United States |
|---|---|
| FDA product code | DSA |
| Device type | Cable, Transducer And Electrode, Patient, (Including Connector) |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2900 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K170385 |
| Record published | 2017-06-06 |
| Record revised | 2024-08-21 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 400-0100.17 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Unimed | Unimed Medical Supplies Inc | 5,928 |
| AMC | LifeSync Corporation | 1,058 |
| Fogg System Company, Inc. | Fogg System Company, Inc. | 693 |
| Multi-Link™ | AirLife Finland Oy | 611 |
| Cable, Transducer And Electrode, Patient, (Including Connector) | ConMed Corporation | 284 |
| Maguire | Maguire Enterprises, Inc. | 193 |
| MediChoice | Owens & Minor Distribution, Inc. | 160 |
| Vermed | Graphic Controls Acquisition Corporation | 159 |
| Vital Signs™ | AirLife Finland Oy | 136 |
| Multi-Link™ | Carefusion Finland 320 Oy | 136 |
| Med-link | Shenzhen MED-Link Electronics Tech Co., Ltd. | 129 |
| Conmed | ConMed Corporation | 106 |
Showing 12 of 1,260. All products under Cable, Transducer And Electrode, Patient, (Including Connector)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K190078 | 2019-02-11 |
Recalls
1 of these is Class III. 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 |
|---|---|---|---|---|
| 2022-02-03 | Class III | Device Design | Multi-Modality Touch Screen Modules (MM-TSM), used with integrated IVUS systems, may crack, or become damaged, which may affect their usability. They could become non-functional. Therefore, bottom protective beams will be replaced with full | 1358 |
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.