Swan-Ganz HI-Shore True Size
HI Torque SG Flow Directed Monit Cath W/ Bonded Balloon
1manufacturer
1catalogue number
4510(k) clearances naming this product code
7recalls on this code
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
Record
| Listed by | Edwards Lifesciences Technology Sarl, United States |
|---|---|
| FDA product code | DQE |
| Device type | Catheter, Oximeter, Fiber-Optic |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1230 |
| 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. |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| T123F6 | EXTERIOR DIAMETER: 6F (2.0MM), USABLE LENGTH: 110 CM, RECOMMENDED GUIDEWIRE SIZE: 0.030 IN (0.76 MM), MINIMUM INTRODUCER SIZE: 6F (2.0MM) | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ICU Medical | ICU Medical, Inc | 65 |
| Vital Signs™ | AirLife Finland Oy | 12 |
| Swan-Ganz | Edwards Lifesciences Technology Sarl | 7 |
| Edwards Oximetry Central Venous Catheter | Edwards Lifesciences Technology Sarl | 6 |
| Vital Signs | Carefusion Finland 320 Oy | 6 |
| HemoSphere | Edwards Lifesciences Technology Sarl | 5 |
| Swan-Ganz True Size | Edwards Lifesciences Technology Sarl | 3 |
| HemoSphere Alta | Edwards Lifesciences Technology Sarl | 3 |
| Flotrac | Edwards Lifesciences Technology Sarl | 3 |
| Vigileo | Edwards Lifesciences Technology Sarl | 2 |
| ForeSight IQ | Edwards Lifesciences Technology Sarl | 1 |
| Pediasat | Edwards Lifesciences Technology Sarl | 1 |
Showing 12 of 18. All products under Catheter, Oximeter, Fiber-Optic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K160645 | 2016-06-16 |
| K110167 | 2011-02-18 |
| K060093 | 2006-04-28 |
| K053609 | 2006-02-28 |
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
7 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 |
|---|---|---|---|---|---|
| 2021-07-09 | Class II | Process control | There is a potential for internal leaks within catheters. | 70 UNITS | 2024-01-29 |
| 2021-07-09 | Class II | Process control | There is a potential for internal leaks within catheters. | 218 UNITS | 2024-01-29 |
| 2021-07-09 | Class II | Process control | There is a potential for internal leaks within catheters. | 152 units | 2024-01-29 |
| 2021-07-09 | Class II | Process control | There is a potential for internal leaks within catheters. | 178 units | 2024-01-29 |
| 2021-07-09 | Class II | Process control | There is a potential for internal leaks within catheters. | 50 units | 2024-01-29 |
| 2021-07-09 | Class II | Process control | There is a potential for internal leaks within catheters. | 200 UNITS | 2024-01-29 |
| 2020-03-27 | Class II | Under Investigation by firm | Sterile catheter kit packaging compromised. | 597 units | 2021-04-27 |
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.