Temporary Myocardial Heartwire
Temporary Myocardial Heartwire, Quadripolar
3manufacturers in China registered for this device type
27catalogue numbers in this listing
8510(k) clearances naming this product code
2recalls on this 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 | Oscor 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, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2015-10-16 |
| Record revised | 2026-02-04 (version 4) |
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, manufacturing date |
| Storage | Storage environment temperature 5 to 30 °C |
| Sizes | Length 60 to 220 cm |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| TME 224 TC | In distribution | ||
| TME 61 S | Thoracic Needle: Straight | 25 | In distribution |
| TME 227 TS | In distribution | ||
| TME 60 TC | Thoracic Needle: Curved | 25 | In distribution |
| TME 224 TS | Thoracic Needle: Straight | 10 | In distribution |
| TME 60 S | Thoracic Needle: Straight | 25 | In distribution |
| TME 64 TC | Thoracic Needle: Curved | 25 | In distribution |
| TME 66 TC | Length 60 cm | 25 | In distribution |
| TME 61 TC | Thoracic Needle: Curved | 25 | In distribution |
| TME 64 S-3 | In distribution | ||
| TME 225 TC | In distribution | ||
| TME 65 C | Length 60 cm | 25 | In distribution |
| TME 220 VC | Thoracic Needle: Curved | 10 | In distribution |
| TME 64 C | Thoracic Needle: Curved | 25 | In distribution |
| TME 228 TS | In distribution | ||
| TME 66 C | In distribution | ||
| TME 66 TS | Length 60 cm | 25 | In distribution |
| TME 228 TC-2.5 | In distribution | ||
| TME 64 TS | Length 60 cm | 25 | In distribution |
| TME 64 S | In distribution | ||
| TME 228 TC | In distribution | ||
| TME 60 C | Thoracic Needle: Curved | 25 | In distribution |
| TME 61 C | Length 60 cm | 25 | In distribution |
| TME 65 S | In distribution | ||
| TME 62 TS | Length 60 cm | 25 | In distribution |
| TME 223 TS | Thoracic Needle: Straight | 10 | In distribution |
| TME 66 S | 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 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K072770 | 2008-01-22 |
| K884866 | 1989-03-22 |
| K872972 | 1987-12-03 |
| K861403 | 1986-06-27 |
| K850622 | 1985-04-10 |
| K831695 | 1983-10-20 |
| K831804 | 1983-10-20 |
| K830772 | 1983-04-18 |
Recalls
1 of these is Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2018-09-26 | Class I | Device Design | During the use of some TB – Temporary Bipolar Pacing Leads, featuring the 2mm unshrouded connectors, the connector cap housing may slide and potentially expose the connection wire. In some instances, this may cause the wire to be more susce | 36,688 units | 2022-08-04 |
| 2012-07-25 | Class II | Process control | Oscor, Inc. in Palm Harbor, FL is recalling myocardial heart wires, models TME60S, TME64S, TME64C, TME64S-3, TME65S, and TME66S. The recall was initiated due to the spacing between anchoring zig-zag to electrode is out of specification. | 1425 | 2013-12-17 |
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.