WovenFlexie™
Diagnostic Electrode Catheter
5manufacturers in China registered for this device type
10catalogue numbers in this listing
14510(k) clearances naming this product code
5recalls on this code
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 | Boston Scientific Corporation, 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, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-09-24 |
| Record revised | 2026-07-03 (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, expiry date |
| Distribution end date | 2023-12-28 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M0042005970 | 5 F Diameter | In distribution |
| M0045002020 | 2.00 mm Diameter | In distribution |
| M0045FMC007130 | 5 F Diameter | In distribution |
| M0045FMC007110 | 5 F Diameter | In distribution |
| M0042005980 | 5 F Diameter | In distribution |
| M0045FMC007920 | 5 F Diameter | In distribution |
| M0045002030 | 6 F Diameter | In distribution |
| M0042005960 | 1.67 mm Diameter | In distribution |
| M0042005990 | 1.67 mm Diameter | In distribution |
| M0045002050 | 2.00 mm Diameter | Withdrawn |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 |
| 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 |
|---|---|
| K250310 | 2025-06-27 |
| K240366 | 2024-11-01 |
| K233207 | 2023-10-27 |
| K232651 | 2023-09-29 |
| K230503 | 2023-04-25 |
| K220796 | 2022-06-10 |
| K211494 | 2021-09-14 |
| K211375 | 2021-09-10 |
| K192360 | 2019-10-25 |
| K081576 | 2009-02-03 |
| K954651 | 1996-10-22 |
| K953750 | 1996-03-11 |
| K951744 | 1995-05-04 |
| K924163 | 1993-09-03 |
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 |
|---|---|---|---|---|---|
| 2014-11-20 | Class II | Device Design | Some IntellaMap Orion High Resolution Mapping Catheters are exhibiting a failure mode in which a glue bond on the Deployment Interlock Button has been observed to fail in the field. | 184 units | 2016-08-11 |
| 2008-02-14 | Not classified | Nonconforming Material/Component | Package sterile barrier may be breached, compromising sterility. | 827 units total | 2011-01-08 |
| 2008-02-14 | Not classified | Nonconforming Material/Component | Package sterile barrier may be breached, compromising sterility. | 827 units total | 2011-01-08 |
| 2007-06-26 | Not classified | Labeling mix-ups | Product is mislabeled as hexapolar (6 electrodes), but is actually quadripolar (4 electrodes). | 30 units | 2007-11-27 |
| 2005-02-18 | Not classified | Other | The device has the potential for overheating its transformer and has the potential for fire hazard. | 2006-01-30 |
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.