MYO/Wire® Ultra-Thin Temporary Pacing Wires
MYO/Wire® Ultra-Thin Quadpolar - 150cm - White/Blue - Flare/Hook 4/10mm electrode
3manufacturers in China registered for this device type
109catalogue 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 | A & E Medical Corporation, United States |
|---|---|
| FDA product code | LDF |
| Device type | Electrode, Pacemaker, Temporary |
| Device class | Class 2 |
| Regulation | 21 CFR 870.3680 |
| 510(k) | K033858 |
| Record published | 2015-11-11 |
| Record revised | 2025-05-30 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, serial number |
| Packaging | Pack of 20, pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| VO60BB | In distribution | |
| BM608ABBG | In distribution | |
| BM608ABBGSTR | In distribution | |
| S25SOP | In distribution | |
| VF2008ABBWD | In distribution | |
| BM608-8ACBB | In distribution | |
| BM2504AWWD | In distribution | |
| VF608ABBG | In distribution | |
| S60ACWGSTR | In distribution | |
| BMZF605ACBB | In distribution | |
| SF6010ACWGSTR | In distribution | |
| BM608AWW | In distribution | |
| SF6010ACOGSTR | In distribution | |
| BM608ACBB | In distribution | |
| BMZ602ABBG | In distribution | |
| S60B | In distribution | |
| VF608AWWGSTR | In distribution | |
| SO60BGSTR | In distribution | |
| SF608ABSTR | In distribution | |
| BM2004ABBD | In distribution | |
| VF608ABBStr | In distribution | |
| SO60BStr | In distribution | |
| SE60WGSTR | In distribution | |
| VO200WWSN | In distribution | |
| VE60BBD | In distribution | |
| QEF2508AWB2N | In distribution | |
| VF608ABB | In distribution | |
| VE60BBMSTR | In distribution | |
| QF2508PBW2N | In distribution | |
| BM2004ABB | In distribution | |
| QEF608PBW | In distribution | |
| VE60PBB | In distribution | |
| QF2508ABW | In distribution | |
| SF604PBD | In distribution | |
| S60AB | In distribution | |
| QF1808PBW | In distribution | |
| VZ60ABB | In distribution | |
| SF608AB | In distribution | |
| SF604PWD | In distribution | |
| VF2008ABBD | In distribution | |
| VF608ALCBB | In distribution | |
| BM604ABW | In distribution | |
| QF2508ABW2N | In distribution | |
| BM2008ABBSN | In distribution | |
| BM604AWW | In distribution | |
| SF6010AWSTR | In distribution | |
| VF2508ABBSP | In distribution | |
| QF2508PBW | In distribution | |
| SF6010AW | In distribution | |
| BM1804ABB | In distribution | |
| VE250BBD | In distribution | |
| BM608ACBBG | In distribution | |
| SF6010ACBGSTR | In distribution | |
| BM1804ABBN | In distribution | |
| BM608ACBBGSTR | In distribution | |
| VF2004PBBN | In distribution | |
| QF608PBW | In distribution | |
| BM608-12ABBG | In distribution | |
| QEF1504PWB2D | In distribution | |
| VF608AWW | In distribution | |
| SO60WStr | In distribution | |
| QE60BW2D | In distribution | |
| QEF608AWB | In distribution | |
| BM604ABBSTR | In distribution | |
| BM2504ABBD | In distribution | |
| VE60WWG | In distribution | |
| VE60BBStr | In distribution | |
| BM604ABBDS | In distribution | |
| QE200BW2D | In distribution | |
| BM2504ABB | In distribution | |
| BMZF605ACBBG | In distribution | |
| BM604ABB | In distribution | |
| VO60WWG | In distribution | |
| QEF2508ABW2D | In distribution | |
| VF608AWWG | In distribution | |
| S60ACBGSTR | In distribution | |
| BM604PWWMSTR | In distribution | |
| VZ60ACBBG | In distribution | |
| VO60BBG | In distribution | |
| QF908PBW2N | In distribution | |
| QM604PBW2D | In distribution | |
| QEF2008ABW2D | In distribution | |
| VF608AWWSTR | In distribution | |
| BM2004ABBGN | In distribution | |
| VF608ABBD | In distribution | |
| QEF1808PBW | In distribution | |
| SF6010AWGSTR | In distribution | |
| VE60WWGSTR | In distribution | |
| VE60WW | In distribution | |
| BM608ABB | In distribution | |
| V605PBB | In distribution | |
| S60ABSTR | In distribution | |
| BM604ACWWStr | In distribution | |
| VF608ACBBG | In distribution | |
| BMZ602ABB | In distribution | |
| VF2004PWWN | In distribution | |
| VE60BB | In distribution | |
| BM604PBB | In distribution | |
| AU010102 | In distribution | |
| BM604ACBBGSTR | In distribution | |
| BM608ABBSTR | In distribution | |
| QM604ABW | In distribution | |
| QEF608ABW2D | In distribution | |
| SF604PB | In distribution | |
| SO60WGSTR | In distribution | |
| QEF2508AWB2D | In distribution | |
| VF2508AWWD | In distribution | |
| VE180PBB | In distribution | |
| VE120BBCM | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| Helios | Oscor Inc. | 8 |
Showing 12 of 31. All products under Electrode, Pacemaker, Temporary
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 | Closed |
|---|---|---|---|---|---|---|---|
| Alto Development Corp. | 510(k) number | 2011-04-18 | Not classified | Process design | The crimping operation during product production was not performed properly. As such, the pacing wire may separate from the connection pin, which causes non-functionality. | 2,120 individual units (106 boxes) | 2012-02-15 |
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.