Swan-Ganz HI-Shore True Size
Swan-Ganz True Size HI-Shore Monitoring "T" TIP Catheter
1manufacturer
1catalogue number
5510(k) clearances naming this product code
21recalls on this code
Who Else Makes It
Registered in Shandong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Bioxin Medical Co., Ltd. | Weihai | Shandong | Contract manufacturer | 8 |
Record
| Listed by | Edwards Lifesciences Technology Sarl, United States |
|---|---|
| FDA product code | DYG |
| Device type | Catheter, Flow Directed |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1240 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| 510(k) | K160084 |
| Record published | 2016-09-03 |
| Record revised | 2023-12-04 (version 6) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: STORE IN A COOL, DRY PLACE. |
| Packaging | Shipper of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| T111F7 | EXTERIOR DIAMETER: 7 F (2.3MM), USABLE LENGTH: 110 CM, RECOMMENDED GUIDEWIRE SIZE: 0.038 IN (0.97 MM), MINIMUM INTRODUCER SIZE: 8 F (2.7 MM) | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arrow | Teleflex Medical LLC | 115 |
| Transonic | Transonic Systems, Inc. | 12 |
| Corodyn | B. Braun Medical Inc. | 10 |
| Venos Occlusion Balloon Catheter | Oscor Inc. | 9 |
| Swan-Ganz True Size | Edwards Lifesciences Technology Sarl | 9 |
| Graftmaster | Abbott Vascular | 9 |
| Swan-Ganz | Edwards Lifesciences Technology Sarl | 7 |
| Pruitt Occlusion Catheter | Lemaitre Vascular, Inc. | 6 |
| Swan-Ganz VIP | Edwards Lifesciences Technology Sarl | 3 |
| Swan-Ganz | Becton, Dickinson AND Company | 3 |
| Swan Ganz Catheter | Edwards Lifesciences Technology Sarl | 2 |
| Swan-Ganz Ccombo | Edwards Lifesciences Technology Sarl | 2 |
Showing 12 of 23. All products under Catheter, Flow Directed
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K242451 | 2024-12-09 |
| K233983 | 2024-06-27 |
| K233824 | 2024-06-06 |
| K193466 | 2020-02-16 |
| K160084 | 2016-05-03 |
Recalls Naming This Product
4 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 | 2018-12-21 | Class I | Nonconforming Material/Component | These Swan Ganz catheters have incorrect lumen assembly, which causes reversal of the lumens. If the lumens are reversed the clinician may note reverse PA and CVP pressure values and waveforms. | 277 units | 2023-11-02 |
| Edwards Lifesciences Technology Sarl | 510(k) number | 2018-12-21 | Class I | Nonconforming Material/Component | These Swan Ganz catheters have incorrect lumen assembly, which causes reversal of the lumens. If the lumens are reversed the clinician may note reverse PA and CVP pressure values and waveforms. | 875 units | 2023-11-02 |
| Edwards Lifesciences Technology Sarl | 510(k) number | 2018-12-21 | Class I | Nonconforming Material/Component | These Swan Ganz catheters have incorrect lumen assembly, which causes reversal of the lumens. If the lumens are reversed the clinician may note reverse PA and CVP pressure values and waveforms. | 9 units | 2023-11-02 |
| Edwards Lifesciences Technology Sarl | 510(k) number | 2018-12-21 | Class I | Nonconforming Material/Component | These Swan Ganz catheters have incorrect lumen assembly, which causes reversal of the lumens. If the lumens are reversed the clinician may note reverse PA and CVP pressure values and waveforms. | 459 units | 2023-11-02 |
Recalls
12 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 |
|---|---|---|---|---|---|
| 2023-02-14 | Class II | Packaging process control | There is a potential that the distal end of the catheter may be bent beyond its intended curvature and when connected to patient monitoring device, the monitor may display an error message. | 59,094 units | |
| 2023-02-14 | Class II | Packaging process control | There is a potential that the distal end of the catheter may be bent beyond its intended curvature and when connected to patient monitoring device, the monitor may display an error message. | 326 units | |
| 2015-05-05 | Class II | Process control | The product failed to meet the internal established statistical test requirement for heparin activity. | 978 | 2016-10-17 |
| 2012-05-11 | Class II | Process control | The device is being recalled because the firm received multiple complaints related to passage of a J-tip guidewire when inserted through the distal lumen hub of the catheter. | 32,145 units for all products in Recall Event | 2014-06-17 |
| 2012-05-11 | Class II | Process control | The device is being recalled because the firm received multiple complaints related to passage of a J-tip guidewire when inserted through the distal lumen hub of the catheter. | 32,145 units for all products in Recall Event | 2014-06-17 |
| 2012-05-11 | Class II | Process control | The device is being recalled because the firm received multiple complaints related to passage of a J-tip guidewire when inserted through the distal lumen hub of the catheter. | 32,145 units for all products in Recall Event | 2014-06-17 |
| 2012-05-11 | Class II | Process control | The device is being recalled because the firm received multiple complaints related to passage of a J-tip guidewire when inserted through the distal lumen hub of the catheter. | 32,145 units for all products in Recall Event | 2014-06-17 |
| 2012-05-11 | Class II | Process control | The device is being recalled because the firm received multiple complaints related to passage of a J-tip guidewire when inserted through the distal lumen hub of the catheter. | 32,145 units for all products in Recall Event | 2014-06-17 |
| 2012-05-11 | Class II | Process control | The device is being recalled because the firm received multiple complaints related to passage of a J-tip guidewire when inserted through the distal lumen hub of the catheter. | 32,145 units for all products in Recall Event | 2014-06-17 |
| 2012-05-11 | Class II | Process control | The device is being recalled because the firm received multiple complaints related to passage of a J-tip guidewire when inserted through the distal lumen hub of the catheter. | 32,145 units for all products in Recall Event | 2014-06-17 |
| 2012-05-11 | Class II | Process control | The device is being recalled because the firm received multiple complaints related to passage of a J-tip guidewire when inserted through the distal lumen hub of the catheter. | 32,145 units for all products in Recall Event | 2014-06-17 |
| 2012-05-11 | Class II | Process control | The device is being recalled because the firm received multiple complaints related to passage of a J-tip guidewire when inserted through the distal lumen hub of the catheter. | 32,145 units for all products in Recall Event | 2014-06-17 |
| 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”. | 5,756 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”. | 2,091units | 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”. | 37 units | 2011-04-11 |
| 2006-11-27 | Not classified | Other | Misbranding-One lot of Swan-Ganz Thermodilution VIP Catheters, Model 831HF75, lot 246HC197 was labeled with different model information (831F75) on the edge label. The edge label states the model is 831F75 which incorrectly indicates that | 1,110 units | 2012-01-23 |
| 2006-06-21 | Not classified | Other | Edwards Lifesciences Vigilance monitors with software release 5.3 or earlier may improperly cause the monitor to deliver power to the Continuous Cardiac Output (CCO) catheter without alerting the user to this situation. This can result in | 8305 | 2008-08-07 |
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.