Truwave X 3 (3 CC)
Catalogue number PXMK1140, listed by Edwards Lifesciences Technology Sarl, United States, under Transducer, Pressure, Catheter Tip. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
1catalogue number
5510(k) clearances naming this product code
10recalls on this code
Who Else Makes It
Concentrated in Shanghai (1), Guangdong (1), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Suzhou Prosteri Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 20 |
| Beijing Bywave Sensing Medical Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 2 |
Record
| Listed by | Edwards Lifesciences Technology Sarl, United States |
|---|---|
| FDA product code | DXO |
| Device type | Transducer, Pressure, Catheter Tip |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2870 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| 510(k) | K142749 |
| Record published | 2020-11-12 |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Store in a cool, dry place. |
| Packaging | Shipper of 10 |
| Sizes | Total volume 3 ml |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PXMK1140 | Total Volume 3.0000 ml | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Truwave | Edwards Lifesciences Technology Sarl | 456 |
| OptoMonitor 3 | Opsens Inc. | 73 |
| Truwave, Vamp | Edwards Lifesciences Technology Sarl | 45 |
| Truwave, Vamp Plus | Edwards Lifesciences Technology Sarl | 24 |
| PX1800 → Truwave Cables | Edwards Lifesciences Technology Sarl | 22 |
| Truwave, Vamp JR | Edwards Lifesciences Technology Sarl | 12 |
| Truwave Cables | Edwards Lifesciences Technology Sarl | 7 |
| TruWave, Vamp Plus | Becton, Dickinson AND Company | 5 |
| TruWave | Becton, Dickinson AND Company | 4 |
| Comet | Boston Scientific Corporation | 4 |
| Medline Industries, Inc. | Medline Industries, Inc. | 4 |
| Pressure Tubing | Edwards Lifesciences Technology Sarl | 3 |
Showing 12 of 63. All products under Transducer, Pressure, Catheter Tip
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K222216 | 2022-12-22 |
| K171996 | 2017-10-23 |
| K142749 | 2015-01-18 |
| K141495 | 2014-09-03 |
| K053016 | 2005-12-30 |
Recalls Naming This Product
9 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Edwards Lifesciences Technology Sarl | 510(k) number | 2021-05-26 | Class II | Under Investigation by firm | There is a potential that the pressure tubing may detach from the blood sampling system | 460 units | 2023-12-14 |
| Edwards Lifesciences Technology Sarl | 510(k) number | 2021-05-26 | Class II | Under Investigation by firm | There is a potential that the pressure tubing may detach from the blood sampling system | 700 units | 2023-12-14 |
| Edwards Lifesciences Technology Sarl | 510(k) number | 2021-05-26 | Class II | Under Investigation by firm | There is a potential that the pressure tubing may detach from the blood sampling system | 290 units | 2023-12-14 |
| Edwards Lifesciences Technology Sarl | 510(k) number | 2021-05-26 | Class II | Under Investigation by firm | There is a potential that the pressure tubing may detach from the blood sampling system | 2,000 units | 2023-12-14 |
| Edwards Lifesciences Technology Sarl | 510(k) number | 2021-05-26 | Class II | Under Investigation by firm | There is a potential that the pressure tubing may detach from the blood sampling system | 1,679 units | 2023-12-14 |
| Edwards Lifesciences Technology Sarl | 510(k) number | 2021-05-26 | Class II | Under Investigation by firm | There is a potential that the pressure tubing may detach from the blood sampling system | 990 units | 2023-12-14 |
| Edwards Lifesciences Technology Sarl | 510(k) number | 2021-05-26 | Class II | Under Investigation by firm | There is a potential that the pressure tubing may detach from the blood sampling system | 50 units | 2023-12-14 |
| Edwards Lifesciences Technology Sarl | 510(k) number | 2021-05-26 | Class II | Under Investigation by firm | There is a potential that the pressure tubing may detach from the blood sampling system | 90 units | 2023-12-14 |
| Edwards Lifesciences Technology Sarl | 510(k) number | 2015-07-31 | Class II | Device Design | Flow restriction issues in a trifurcated IV set included in the pressure transducer kits. A restriction of the flow of IV fluid would result in either an inability to prime the system before use or difficulty in flushing the line after a bl | 13,077 (U.S.) and 12,306 (International) | 2016-07-08 |
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 | Quantity | Closed |
|---|---|---|---|---|---|
| 2015-11-13 | Class II | Under Investigation by firm | Edward Lifesciences is recalling Intravascular (IV) Administration Sets due to the requirement of an additional FDA submission to support commercialization (clearance) of the devices. | 147,350 units | 2016-07-15 |
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.