Swan-Ganz
Swan-Ganz Hi-Shore True Size Thermodilution Catheters
1manufacturer
3catalogue numbers in this listing
2recalls 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 | Becton, Dickinson AND Company, United States |
|---|---|
| FDA product code | DYG |
| Device type | Catheter, Flow Directed |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1240 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K233824 |
| Record published | 2026-07-24 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| 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; Special storage condition: Special Storage Conditions (see IFU) |
| Packaging | Case of 5 |
| Sizes | Length 110 cm; outer diameter 2.3 to 2.5 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 141F7 | Recommended Guidewire Size [EN] = 0.025 inch (in) | In distribution |
| 131F7P | Recommended Guidewire Size [EN] = 0.025 inch (in) | In distribution |
| 831F75P | Minimum Introducer Size [EN] = 8.5 French (F) | 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 Catheter | Edwards Lifesciences Technology Sarl | 2 |
| Swan-Ganz Ccombo | Edwards Lifesciences Technology Sarl | 2 |
| Cook | Cook Incorporated | 2 |
Showing 12 of 23. All products under Catheter, Flow Directed
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Becton, Dickinson AND Company | 510(k) number | 2026-04-08 | Class II | Process change control | Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss. | 183 |
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 |
|---|---|---|---|---|
| 2026-04-08 | Class II | Process change control | Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss. | 53 |
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.