Flexon
Multifilament Temporary Cardiac Pacing Lead
3manufacturers in China registered for this device type
13catalogue numbers in this listing
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 | Covidien LP, United States |
|---|---|
| FDA product code | LDF |
| Device type | Electrode, Pacemaker, Temporary |
| Device class | Class 2 |
| Regulation | 21 CFR 870.3680 |
| 510(k) | K955722 |
| Record published | 2018-08-10 |
| Record revised | 2025-06-24 (version 12) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature up to 130 °F |
| Packaging | Case of 12 |
| Sizes | Length 24 in |
| Distribution end date | 2026-04-07 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8886258643-2 | diameter,3/0,N/A; | In distribution |
| 88862592-43 | Length 24 in | In distribution |
| 8886259243-2 | diameter,3/0,N/A; | In distribution |
| 88862615-53 | Length 24 in | In distribution |
| 88862591-43 | Length 24 in | In distribution |
| 88862623-53 | Length 24 in | In distribution |
| 88862593-63 | Length 24 in | In distribution |
| 8886259363-2 | diameter,0,N/A; | In distribution |
| 88862589-63 | Length 24 in | In distribution |
| 88862586-43 | diameter,3/0,N/A; | Withdrawn |
| 88862597-63 | Length 24 in | Withdrawn |
| 8886259143-2 | Length 24 in | Withdrawn |
| 88862617-53 | Length 24 in | Withdrawn |
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 |
| 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 |
| Helios | Oscor Inc. | 8 |
Showing 12 of 31. All products under Electrode, Pacemaker, Temporary
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.