Achieve Advance™
Achieve Advance is an intracardiac electrophysiology catheter that records atrial electrical signals and provides cardiac stimulation during electrophysiology studies. Its distal mapping…
Achieve Advance is an intracardiac electrophysiology catheter that records atrial electrical signals and provides cardiac stimulation during electrophysiology studies. Its distal mapping section forms a circular loop with evenly spaced electrodes. The range includes pre-shaped loop diameters of 15, 20 and 25 mm.
The catheter is intended for multielectrode mapping, recording and stimulation only. It is delivered through a delivery catheter and has an effective length of 146 cm with a 3.3 Fr body. The 15 and 20 mm loop configurations have eight electrodes.
Listed Item
Catheter 2ACH20 20MM Diameter US
Body and Loop Materials
The distal body combines nitinol and Pebax, while the proximal section uses stainless steel and polyimide. The loop uses nitinol insulated with PET and covered with Pebax. These structural sections support the loop and electrode arrangement for obtaining atrial electrograms.
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) | K162892 |
| Record published | 2016-12-26 |
| Record revised | 2024-10-28 (version 3) |
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 | Special storage condition: Keep dry; Storage environment humidity up to 85 % RH; Special storage condition: Keep away from sunlight; Storage environment temperature 59 to 86 °F; Handling environment temperature -31 to 136 °F |
| Sizes | Length 165 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2ACH20 | Catheter diameter 1.1 mm (3.3 Fr) | In distribution |
| 2ACH15 | Length 165.0 cm | In distribution |
| 2ACH25 | Length 165.0 cm | In distribution |
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 |
| Catheter, Electrode Recording, Or Probe, Electrode Recording | Medtronic, Inc. | 27 |
| Lasso NAV | Biosense Webster, Inc. | 22 |
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
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 |
|---|---|---|---|---|---|
| 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.