Electrode, Pacemaker, Temporary
Balloon Bipolar Temporary Pacing Electrode Catheter, Right Heart Curve, Stainless Steel Electrodes
3manufacturers in China registered for this device type
10catalogue numbers in this listing
8510(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 | C.R. Bard, Inc., United States |
|---|---|
| FDA product code | LDF |
| Device type | Electrode, Pacemaker, Temporary |
| Device class | Class 2 |
| Regulation | 21 CFR 870.3680 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2015-06-29 |
| Record revised | 2026-06-03 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| 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 |
| Storage | Special storage condition: Keep away from sunlight |
| Packaging | Case of 5, case of 50 |
| Sizes | Catheter gauge 4 to 7 Fr; length 110 to 125 cm |
| Distribution end date | 2021-01-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 006241P | Catheter Gauge 6 Fr | In distribution |
| 108154P | Catheter Gauge 5 Fr | In distribution |
| 106173P | Catheter Gauge 5 Fr | In distribution |
| 006242P | Length 125 cm | In distribution |
| 006172P | Length 110 cm | In distribution |
| 006225P | Catheter Gauge 5 Fr | In distribution |
| 520007P | Length 110 cm | In distribution |
| 006221P | Length 115 cm | In distribution |
| 006173P | Length 110 cm | In distribution |
| 006395P | Catheter Gauge 6 Fr | Withdrawn |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 |
| Flexon | Covidien LP | 13 |
| Electrode, Pacemaker, Temporary | Medtronic, Inc. | 12 |
| Nbih™ Temporary Pacing Electrode Catheter | C.R. Bard, Inc. | 11 |
| Streamline™ | Medtronic, Inc. | 10 |
| Steelex | B Braun Surgical SA | 9 |
| Helios | Oscor Inc. | 8 |
Showing 12 of 31. All products under Electrode, Pacemaker, Temporary
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K251186 | 2025-05-15 |
| K241334 | 2025-01-31 |
| K955712 | 1996-10-11 |
| K882330 | 1988-09-06 |
| K852513 | 1985-09-16 |
| K830094 | 1983-02-18 |
| K812307 | 1981-09-21 |
| K800298 | 1980-04-16 |
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.