Electrode, Pacemaker, Temporary
Cable 5833SL SURGICAL5PK Disp SM 12FT US
3manufacturers in China registered for this device type
12catalogue numbers in this listing
5510(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 | Medtronic, Inc., United States |
|---|---|
| FDA product code | LDF |
| Device type | Electrode, Pacemaker, Temporary |
| Device class | Class 2 |
| Regulation | 21 CFR 870.3680 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K923407 |
| Record published | 2015-06-10 |
| Record revised | 2024-03-20 (version 6) |
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 |
| Storage | Handling environment temperature -31 to 136 °F; Storage environment humidity up to 85 % RH |
| Packaging | Pack of 5 |
| Sizes | Length 100 to 366 cm; length 6 to 12 ft |
| Distribution end date | 2022-05-10 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 5833S | Length 6.0 ft | In distribution | |
| 5833SL | Length 366.0 cm | In distribution | |
| 5833SL | Length 12.0 ft | In distribution | |
| 6416-140 | Length 140.0 cm | In distribution | |
| 6416-100 | Length 100.0 cm | Withdrawn | |
| 6416-140 | Lead length 140 cm | 5 | Withdrawn |
| 6416-200 | Length 200.0 cm | Withdrawn | |
| 6416-200S | Catheter length 90 cm | Withdrawn | |
| 6416-100 | Lead length 100 cm | 5 | Withdrawn |
| 6416-200 | Catheter length 90 cm | 5 | Withdrawn |
| 6416-100S | Lead length 100 cm | Withdrawn | |
| 6416-140S | Catheter length 60 cm | Withdrawn |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 |
| 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 |
|---|---|
| K242705 | 2025-01-17 |
| K190716 | 2019-08-08 |
| K171253 | 2017-05-25 |
| K161249 | 2016-08-19 |
| K140972 | 2014-06-06 |
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 |
|---|---|---|---|---|---|---|---|
| Medtronic, Inc. | 510(k) number | 2016-06-16 | Class II | Nonconforming Material/Component | This Pacing Lead System does not comply with Section 8.5.2.3 of IEC 60601-1, and corresponding provisions of FDA 21 CFR 898, which relate to design standards to prevent connecting a patients lead to a possible hazardous voltage. | 11697 (5523 OUS, 6174 US) | 2018-02-13 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2009-02-06 | Not classified | Process control | Medtronic is recalling one lot of STREAMLINE Bipolar Myocardial Temporary Pacing Leads, Model 6495, Lot JGD880205F. This lot of product contains incorrect inner pouch labeling, instead of 6495 it is labeled 6500. The outer carton, shelf b | 612 | 2011-05-07 |
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.