Catheter, Electrode Recording, or Probe, Electrode Recording
Cable 990066 Achieve Electrical Global
5manufacturers in China registered for this device type
27catalogue numbers in this listing
5510(k) clearances naming this product code
1recall
Who Else Makes It
Concentrated in Jiangsu (2), Tianjin (1), Shanghai (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangyin Sinbon Electronics Co Ltd | Jiangyin | Jiangsu | Contract manufacturer | 13 |
| Palconn Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 2 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Tianjin Ethylene Oxide Sterilization Technology Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 4 |
| Shanghai Microport EP Medtech Co., Ltd. | Shanghai | Shanghai | Manufacturer | 3 |
Record
| Listed by | Medtronic, Inc., United States |
|---|---|
| FDA product code | DRF |
| Device type | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1220 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K923915 |
| Record published | 2024-08-22 |
| Record revised | 2023-07-31 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide, Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Storage | Special storage condition: Keep dry |
| Sizes | Length 122 to 244 cm; length 1.96 m; length 77 in |
| Distribution end date | 2024-03-08 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 05518SP | Length 244.0 cm | In distribution | |
| 05514SP | Length 122.0 cm | In distribution | |
| 05504SP | Length 122.0 cm | In distribution | |
| 05518SP | Length 244.0 cm | In distribution | |
| 2ACHC | Length 77.0 in | In distribution | |
| 05508SP | Length 244.0 cm | In distribution | |
| 61399400072 | 10 | In distribution | |
| 05518SP | Length 244.0 cm | In distribution | |
| 5410S | In distribution | ||
| 2ACHC | Length 1.96 m | In distribution | |
| 05508SP | Length 244.0 cm | In distribution | |
| 05504SP | Length 122.0 cm | In distribution | |
| 2ACHC | Length 1.96 m | In distribution | |
| 2ACHC | Length 1.96 m | In distribution | |
| 2ACHC | Length 1.96 m | In distribution | |
| 2ACHC | Length 1.96 m | In distribution | |
| 05514SP | Length 122.0 cm | In distribution | |
| 1384 | In distribution | ||
| 05508SP | Length 244.0 cm | In distribution | |
| 05518SP | Length 244.0 cm | In distribution | |
| 05514SP | Length 122.0 cm | In distribution | |
| 05504SP | Length 122.0 cm | Withdrawn | |
| 990066 | Withdrawn | ||
| 05514SP | Length 122.0 cm | Withdrawn | |
| 05504SP | Length 122.0 cm | Withdrawn | |
| 05508SP | Length 244.0 cm | Withdrawn | |
| 990066 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Map-iT | Access Point Medical, LLC | 420 |
| Woven | Boston Scientific Corporation | 126 |
| Inquiry™ | Irvine Biomedical. Inc. | 122 |
| Webster | Biosense Webster, Inc. | 121 |
| Viking™ | Boston Scientific Corporation | 81 |
| EasyFinder Fixed Curve Diagnostic Catheter | Shanghai Microport EP Medtech Co., Ltd. | 56 |
| Supreme™ | St. Jude Medical Cardiovascular Division | 55 |
| Celsius | Biosense Webster, Inc. | 47 |
| Response™ | St. Jude Medical Cardiovascular Division | 46 |
| Torqr™ | Medtronic, Inc. | 32 |
| Lasso NAV | Biosense Webster, Inc. | 22 |
| AcQRate Dx Fixed Curve Catheter | VascoMed GmbH | 20 |
Showing 12 of 112. All products under Catheter, Electrode Recording, Or Probe, Electrode Recording
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K233397 | 2023-12-02 |
| K190132 | 2019-07-30 |
| K183547 | 2019-07-30 |
| K162892 | 2016-11-15 |
| K153139 | 2016-05-06 |
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 | 2015-09-29 | Class II | Under Investigation by firm | 64 units of Achieve Electrical Cables were shipped with a potential sterility breach. | 64 units | 2016-03-09 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P950005 | 2001-10-05 | CELSIUS DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER | Biosense Webster, Inc. |
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.