C3 Wave System
C3 Accessory Pack (Remote CVR & Clip/Cable) - US
5manufacturers in China registered for this device type
18catalogue numbers in this listing
10510(k) clearances naming this product code
40recalls on this code
Who Else Makes It
Concentrated in Guangdong (3), Zhejiang (1), 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 |
|---|---|---|---|---|
| Hantech Medical Device Co., Ltd. | Cixi | Zhejiang | Contract manufacturer | 18 |
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
| Taijia Medical Electronics (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 10 |
| Chison Medical Technologies Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 5 |
| Haolang Technology (Foshan) Limited Corporation | Foshan | Guangdong | Contract manufacturer | 6 |
Record
| Listed by | AngioDynamics, Inc., United States |
|---|---|
| FDA product code | LJS |
| Device type | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5970 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2022-04-08 |
| Record revised | 2024-03-25 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature up to 27 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MRC3R003 | In distribution | |
| MRC3RD004 | In distribution | |
| MRC3S95 | In distribution | |
| MRC3RD003 | In distribution | |
| MRC3R000 | In distribution | |
| MRC3S90 | In distribution | |
| MRC3S92 | In distribution | |
| MRC3S02US | In distribution | |
| MRC3S915 | In distribution | |
| MRC3S92 | In distribution | |
| MRC3RD000 | In distribution | |
| MRC3S94 | In distribution | |
| MRC3S01US | In distribution | |
| MRC3S97 | In distribution | |
| MRC3S91 | In distribution | |
| MRC3S916 | In distribution | |
| MRC3S93 | In distribution | |
| MRC3S96 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arrow | Teleflex Medical LLC | 1,548 |
| BioFlo | Navilyst Medical, Inc. | 658 |
| PowerPICC | Bard Access Systems, Inc. | 477 |
| PowerPICC Solo | Bard Access Systems, Inc. | 333 |
| PowerPICC Provena | Bard Access Systems, Inc. | 312 |
| Xcela | Navilyst Medical, Inc. | 271 |
| PRO-Picc® CT | Medical Components Inc | 157 |
| Vascu-Picc® | Medical Components Inc | 135 |
| Turbo-Ject | Cook Incorporated | 94 |
| Cook Spectrum Turbo-Ject | Cook Incorporated | 73 |
| Vascu-Picc®and Midline Catheters | Medical Components Inc | 55 |
| Synergy | Health Line International Corporation | 53 |
Showing 12 of 194. All products under Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K142889 | 2015-01-27 |
| K093406 | 2010-03-25 |
| K072196 | 2007-08-27 |
| K070613 | 2007-06-29 |
| K070615 | 2007-05-04 |
| K060887 | 2006-04-28 |
| K041420 | 2004-07-26 |
| K040446 | 2004-03-05 |
| K031626 | 2003-06-19 |
| K030415 | 2003-04-30 |
Recalls
40 of these are 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 | Quantity | Closed |
|---|---|---|---|---|---|
| 2020-05-04 | Class II | Process control | Certain AngioDynamics PICC Kits contain BD PosiFlush SF Saline Flush Syringes which were recalled by BD Medical on April 16, 2020. | 119723 eaches total | 2023-08-23 |
| 2020-05-04 | Class II | Process control | Certain AngioDynamics PICC Kits contain BD PosiFlush SF Saline Flush Syringes which were recalled by BD Medical on April 16, 2020. | 119723 eaches total | 2023-08-23 |
| 2018-10-16 | Class II | Under Investigation by firm | specific lots of Xcela Power Injectable and BioFlo PICCs are labelled with incorrect expiration dates. The labelled expiration date extends the shelf life of the product beyond the date supported by validation testing. Although the product | Box of 4 units | 2020-06-26 |
| 2018-10-16 | Class II | Under Investigation by firm | Specific lots of Xcela Power Injectable and BioFlo PICCs are labelled with incorrect expiration dates. The labelled expiration date extends the shelf life of the product beyond the date supported by validation testing. Although the product | Box of 1 Units | 2020-06-26 |
| 2018-05-10 | Class II | Material/Component Contamination | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). | 11 boxes | 2020-05-13 |
| 2018-05-10 | Class II | Material/Component Contamination | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). | 15 boxes | 2020-05-13 |
| 2018-05-10 | Class II | Material/Component Contamination | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). | 2 boxes | 2020-05-13 |
| 2018-05-10 | Class II | Material/Component Contamination | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). | 132 boxes | 2020-05-13 |
| 2018-05-10 | Class II | Material/Component Contamination | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). | 246 boxes | 2020-05-13 |
| 2018-05-10 | Class II | Material/Component Contamination | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). | 20 boxes | 2020-05-13 |
| 2018-05-10 | Class II | Material/Component Contamination | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). | 6 boxes | 2020-05-13 |
| 2018-05-10 | Class II | Material/Component Contamination | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). | 12 boxes | 2020-05-13 |
| 2018-05-10 | Class II | Material/Component Contamination | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). | 7 boxes | 2020-05-13 |
| 2018-05-10 | Class II | Material/Component Contamination | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). | 17 boxes | 2020-05-13 |
| 2018-05-10 | Class II | Material/Component Contamination | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). | 13 boxes | 2020-05-13 |
| 2018-05-10 | Class II | Material/Component Contamination | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). | 200 boxes | 2020-05-13 |
| 2018-05-10 | Class II | Material/Component Contamination | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). | 17 boxes | 2020-05-13 |
| 2018-05-10 | Class II | Material/Component Contamination | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). | 298 boxes | 2020-05-13 |
| 2018-05-10 | Class II | Material/Component Contamination | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). | 2 boxes | 2020-05-13 |
| 2018-05-10 | Class II | Material/Component Contamination | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). | 50 boxes | 2020-05-13 |
| 2018-05-10 | Class II | Material/Component Contamination | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). | 79 boxes | 2020-05-13 |
| 2018-05-10 | Class II | Material/Component Contamination | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). | 2 boxes | 2020-05-13 |
| 2018-05-10 | Class II | Material/Component Contamination | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). | 7 | 2020-05-13 |
| 2018-05-10 | Class II | Material/Component Contamination | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). | 81 boxes | 2020-05-13 |
| 2018-05-10 | Class II | Material/Component Contamination | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). | 3 boxes | 2020-05-13 |
| 2018-05-10 | Class II | Material/Component Contamination | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). | 12 boxes | 2020-05-13 |
| 2018-05-10 | Class II | Material/Component Contamination | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). | 7 boxes | 2020-05-13 |
| 2018-05-10 | Class II | Material/Component Contamination | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). | 1 box | 2020-05-13 |
| 2018-05-10 | Class II | Material/Component Contamination | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). | 20 boxes | 2020-05-13 |
| 2018-05-10 | Class II | Material/Component Contamination | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). | 5 boxes | 2020-05-13 |
| 2018-05-10 | Class II | Material/Component Contamination | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). | 11 boxes | 2020-05-13 |
| 2018-05-10 | Class II | Material/Component Contamination | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). | 58 boxes | 2020-05-13 |
| 2018-05-10 | Class II | Material/Component Contamination | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). | 27 boxes | 2020-05-13 |
| 2018-05-10 | Class II | Material/Component Contamination | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). | 7 boxes | 2020-05-13 |
| 2018-05-10 | Class II | Material/Component Contamination | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). | 36 boxes | 2020-05-13 |
| 2018-05-10 | Class II | Material/Component Contamination | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). | 99 boxes | 2020-05-13 |
| 2018-05-10 | Class II | Material/Component Contamination | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). | 104 boxes | 2020-05-13 |
| 2018-05-10 | Class II | Material/Component Contamination | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). | 2 boxes | 2020-05-13 |
| 2016-11-28 | Class II | Component design/selection | Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV and the BioFlo PICC, conducted this recall to the end user level based on information received from Greatbatch Medical, the manufacturer of the | 4591 units in total | 2019-06-12 |
| 2016-11-28 | Class II | Component design/selection | Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV and the BioFlo PICC, conducted this recall to the end user level based on information received from Greatbatch Medical, the manufacturer of the | 4591 units in total | 2019-06-12 |
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.