Myo/Wire
Extended Length Temp Pacing Wire
3manufacturers in China registered for this device type
76catalogue 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) | K803086 |
| Record published | 2015-09-15 |
| Record revised | 2025-05-30 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 24, pack of 12, pack of 6, pack of 4 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 026-400 | In distribution | |
| 022-011 | In distribution | |
| 025-202 | In distribution | |
| 026-201 | In distribution | |
| 025-310 | In distribution | |
| 024-110 | In distribution | |
| 022-001 | In distribution | |
| 025-200 | In distribution | |
| 024-410 | In distribution | |
| 026-402 | In distribution | |
| 025-201 | In distribution | |
| 024-310 | In distribution | |
| 025-101 | In distribution | |
| 024-300 | In distribution | |
| 029-031 | In distribution | |
| 026-401 | In distribution | |
| 024-200 | In distribution | |
| 021-000 | In distribution | |
| 024-400 | In distribution | |
| 030-005 | In distribution | |
| 029-013 | In distribution | |
| 030-003 | In distribution | |
| 021-010 | In distribution | |
| 024-101 | In distribution | |
| 025-211 | In distribution | |
| 024-210 | In distribution | |
| 025-100 | In distribution | |
| 020-011 | In distribution | |
| 025-400 | In distribution | |
| 027-044 | In distribution | |
| 024-301 | In distribution | |
| 021-002 | In distribution | |
| 029-030 | In distribution | |
| 024-201 | In distribution | |
| 020-000 | In distribution | |
| 024-311 | In distribution | |
| 025-311 | In distribution | |
| 021-001 | In distribution | |
| 024-401 | In distribution | |
| 024-402 | In distribution | |
| 027-522 | In distribution | |
| 025-301 | In distribution | |
| 029-036 | In distribution | |
| 024-211 | In distribution | |
| 030-001 | In distribution | |
| 030-002 | In distribution | |
| 029-006 | In distribution | |
| 024-202 | In distribution | |
| 029-015 | In distribution | |
| 022-000 | In distribution | |
| 024-100 | In distribution | |
| 029-047 | In distribution | |
| 026-100 | In distribution | |
| 024-212 | In distribution | |
| 029-016 | In distribution | |
| 026-101 | In distribution | |
| 027-043 | In distribution | |
| 027-525 | In distribution | |
| 021-011 | In distribution | |
| 030-006 | In distribution | |
| 030-007 | In distribution | |
| 026-200 | In distribution | |
| 025-102 | In distribution | |
| 029-044 | In distribution | |
| 024-411 | In distribution | |
| 027-523 | In distribution | |
| 030-004 | In distribution | |
| 025-210 | In distribution | |
| 020-010 | In distribution | |
| 020-001 | In distribution | |
| 029-004 | In distribution | |
| 020-002 | In distribution | |
| 022-010 | In distribution | |
| 029-014 | In distribution | |
| 025-300 | In distribution | |
| 027-524 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MYO/Wire® Ultra-Thin Temporary Pacing Wires | A & E Medical Corporation | 109 |
| 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
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Medline Industries, LP – Northfield | 510(k) number | 2024-04-08 | Class II | Under Investigation by firm | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health. | ||
| Medline Industries, LP – Northfield | 510(k) number | 2024-04-08 | Class II | Under Investigation by firm | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health. | ||
| Alto Development Corp. | 510(k) number | 2019-06-21 | Class II | Labeling Change Control | Updated instructions for use: Ultra-Flex MYO/WIRE Monopolar pacing wire looped electrode (M-21 Series) to be consistent between electrode IFU and instructions for M-21 loop. | 351.5 Boxes | 2020-05-13 |
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.