Truwave
Catalogue number PXVPL20001, listed by Edwards Lifesciences Technology Sarl, United States, under Catheter, Continuous Flush. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
1catalogue number
4510(k) clearances naming this product code
4recalls on this code
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (1), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Wallaby Medical Technologies Co., Inc. | Shanghai | Shanghai | Contract manufacturer | 5 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Suzhou Zenith Vascular Scitech Limited | Suzhou | Jiangsu | Manufacturer | 6 |
| Suzhou Hengrui Hongyuan Medical Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 3 |
| Vascupatent Medical (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 1 |
Record
| Listed by | Edwards Lifesciences Technology Sarl, United States |
|---|---|
| FDA product code | KRA |
| Device type | Catheter, Continuous Flush |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1210 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| 510(k) | K141495 |
| Record published | 2019-07-09 |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PXVPL20001 | Total Volume: 3 cc, Length: 85 Inch (216 Centimeter) | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Fountain® | Merit Medical Systems, Inc. | 154 |
| PulseSpray | AngioDynamics, Inc. | 149 |
| Merit Maestro® | Merit Medical Systems, Inc. | 143 |
| Phenom™ Catheter | Cathera, Inc. | 103 |
| UniFuse | AngioDynamics, Inc. | 84 |
| CXI | Cook Incorporated | 48 |
| Uni-Fuse+ | AngioDynamics, Inc. | 32 |
| Prowler | Medos International Sàrl | 27 |
| Truwave, Vamp | Edwards Lifesciences Technology Sarl | 26 |
| ICU Medical | ICU Medical, Inc | 21 |
| Cantata | Cook Incorporated | 20 |
| Truwave, Vamp Plus | Edwards Lifesciences Technology Sarl | 19 |
Showing 12 of 149. All products under Catheter, Continuous Flush
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K181684 | 2018-11-08 |
| K180275 | 2018-10-24 |
| K173586 | 2018-04-05 |
| K161962 | 2016-11-28 |
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 |
|---|---|---|---|---|---|
| 2013-01-30 | Class II | Process change control | The device is being recalled because the firm has received multiple complaints related to incorrect assembly that may result in dilution of blood samples. | 30,467 | 2016-03-10 |
| 2009-02-09 | Not classified | Software design | Cardiac output measurements were unavailable and the following message is displayed in the Vigilance monitor: “Fault. CCO Catheter Verification. Use Bolus Mode”. | 2,728 units | 2011-04-11 |
| 2009-02-09 | Not classified | Software design | Cardiac output measurements were unavailable and the following message is displayed in the Vigilance monitor: “Fault. CCO Catheter Verification. Use Bolus Mode”. | 107 units | 2011-04-11 |
| 2009-02-09 | Not classified | Software design | Cardiac output measurements were unavailable and the following message is displayed in the Vigilance monitor: “Fault. CCO Catheter Verification. Use Bolus Mode”. | 35 units | 2011-04-11 |
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.