Helios
8 catalogue numbers from H05RH110U, listed by Oscor Inc., United States, under Electrode, Pacemaker, Temporary. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
8catalogue 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 |
| 510(k) | K072770 |
| Record published | 2015-10-16 |
| Record revised | 2026-02-04 (version 5) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| H05RH110U | In distribution | |
| H05110S | In distribution | |
| HRHCK05110S | In distribution | |
| HK05110U | In distribution | |
| HRHCK05110U | In distribution | |
| HK05110S | In distribution | |
| H05RH110S | In distribution | |
| H05110U | 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 |
| 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 |
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 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 |
|---|---|---|---|---|---|---|---|
| Oscor Inc. | 510(k) number | 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 |
Recalls
1 of these is Class II. 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 |
|---|---|---|---|---|---|
| 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.