Swan-Ganz
Swan-Ganz Pacing TD Catheter
3manufacturers in China registered for this device type
1catalogue number
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (2), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dongguan King Medical Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 14 |
| Shenzhen Launch Electrical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Bioxin Medical Co., Ltd. | Weihai | Shandong | Contract manufacturer | 8 |
Record
| Listed by | Edwards Lifesciences Technology Sarl, United States |
|---|---|
| FDA product code | LDF |
| Device type | Electrode, Pacemaker, Temporary |
| Device class | Class 2 |
| Regulation | 21 CFR 870.3680 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| 510(k) | K233983 |
| Record published | 2016-09-03 |
| Record revised | 2025-06-09 (version 4) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| 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. |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| D200F7 | Exterior Diameter: 7F (2.3 mm), Usable Length: 110 cm, Minimum Guidewire Size: 0.020 in (0.51mm), Exterior Diameter: 8F (2.7mm) | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MYO/Wire® Ultra-Thin Temporary Pacing Wires | A & E Medical Corporation | 109 |
| Myo/Wire | A & E Medical Corporation | 76 |
| TB | Oscor Inc. | 40 |
| Temporary Myocardial Heartwire | Oscor Inc. | 27 |
| Pacel™ | St. Jude Medical Cardiovascular Division | 16 |
| Ethicon | Ethicon, Inc. | 15 |
| Flexon | Covidien LP | 13 |
| Electrode, Pacemaker, Temporary | Medtronic, Inc. | 12 |
| Nbih™ Temporary Pacing Electrode Catheter | C.R. Bard, Inc. | 11 |
| Electrode, Pacemaker, Temporary | C.R. Bard, Inc. | 10 |
| Streamline™ | Medtronic, Inc. | 10 |
| Steelex | B Braun Surgical SA | 9 |
Showing 12 of 31. All products under Electrode, Pacemaker, Temporary
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K152633 | 2015-10-15 |
| K791183 | 1979-07-12 |
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. | 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.