EasyFinder Fixed Curve Diagnostic Catheter
EasyFinder Fixed Curve is a diagnostic electrophysiology catheter for recording electrograms and stimulating the heart during diagnostic studies. An array of platinum electrodes sits along…
EasyFinder Fixed Curve is a diagnostic electrophysiology catheter for recording electrograms and stimulating the heart during diagnostic studies. An array of platinum electrodes sits along its fixed distal curve.
The high-torque shaft lets the operator rotate the plane of that curve to position the catheter tip. The family includes 28 models across six curve types.
Equipment Connection and Supply
A FORLNK mapping-catheter cable connects the catheter to separately cleared diagnostic electrophysiology equipment. The catheter is supplied sterile after ethylene-oxide sterilization and is intended for a single use. Its fixed-curve configuration and external equipment connection serve different parts of the mapping setup.
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 | Shanghai Microport EP Medtech Co., Ltd., China |
|---|---|
| FDA product code | DRF |
| Device type | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1220 |
| Establishment | Manufacturer |
| 510(k) | K210313 |
| Record published | 2024-02-21 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EPD6FB005 | In distribution | |
| EPD6AD252 | In distribution | |
| EPD6AB010 | In distribution | |
| EPD6DC282 | In distribution | |
| EPD5JG010 | In distribution | |
| EPD5CG010 | In distribution | |
| EPD6AB252 | In distribution | |
| EPD5PE282 | In distribution | |
| EPD6PE282 | In distribution | |
| EPD6FB010 | In distribution | |
| EPD6FD005 | In distribution | |
| EPD6DB010 | In distribution | |
| EPD6AD010 | In distribution | |
| EPD6FB252 | In distribution | |
| EPD5JG010 | In distribution | |
| EPD5CG010 | In distribution | |
| EPD6DB005 | In distribution | |
| EPD6JG010 | In distribution | |
| EPD6PC282 | In distribution | |
| EPD6FB005 | In distribution | |
| EPD6DD252 | In distribution | |
| EPD5PE282 | In distribution | |
| EPD6DD010 | In distribution | |
| EPD6AB005 | In distribution | |
| EPD6FD252 | In distribution | |
| EPD6DD005 | In distribution | |
| EPD6DC282 | In distribution | |
| EPD6FD005 | In distribution | |
| EPD6AD005 | In distribution | |
| EPD6JG010 | In distribution | |
| EPD5PC282 | In distribution | |
| EPD6FD010 | In distribution | |
| EPD6AB252 | In distribution | |
| EPD6PE282 | In distribution | |
| EPD6PE282 | In distribution | |
| EPD6FB252 | In distribution | |
| EPD6AB010 | In distribution | |
| EPD6AB005 | In distribution | |
| EPD6DB252 | In distribution | |
| EPD6AD005 | In distribution | |
| EPD6AD010 | In distribution | |
| EPD6FB010 | In distribution | |
| EPD6PC282 | In distribution | |
| EPD6AD252 | In distribution | |
| EPD6DD252 | In distribution | |
| EPD6FD252 | In distribution | |
| EPD6DB252 | In distribution | |
| EPD6FD010 | In distribution | |
| EPD6CG010 | In distribution | |
| EPD6CG010 | In distribution | |
| EPD5PC282 | In distribution | |
| EPD6DE282 | In distribution | |
| EPD6AB010 | In distribution | |
| EPD6DD010 | In distribution | |
| EPD6DD005 | In distribution | |
| EPD6DB005 | 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 |
| 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 |
| 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 |
|---|---|
| K210313 | 2022-12-30 |
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.