Decanav
2 catalogue numbers from R7D282CT, listed by Biosense Webster, Inc., United States, under Catheter, Electrode Recording, Or Probe, Electrode Recording. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
2catalogue numbers in this listing
19510(k) clearances naming this product code
15recalls 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 | Biosense Webster, 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, Complaint-file establishment, Manufacturer |
| 510(k) | K080425 |
| Record published | 2016-09-16 |
| Record revised | 2025-12-02 (version 7) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Do not use if package is opened; Special storage condition: Do not use if package is damaged; Special storage condition: Keep Dry; Special storage condition: Keep out of direct sunlight |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| R7D282CT | In distribution | |
| R7F282CT | 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 |
|---|---|
| K211219 | 2022-01-26 |
| K193632 | 2020-06-30 |
| K130602 | 2013-08-14 |
| K113213 | 2011-12-05 |
| K101991 | 2011-05-02 |
| K101345 | 2010-06-22 |
| K093376 | 2010-06-18 |
| K090898 | 2009-09-04 |
| K090120 | 2009-03-24 |
| K081258 | 2009-01-06 |
| K080425 | 2008-04-23 |
| K061468 | 2006-08-14 |
| K061463 | 2006-08-14 |
| K060047 | 2006-06-19 |
| K052083 | 2005-09-29 |
| K042998 | 2005-09-29 |
| K050877 | 2005-06-24 |
| K031161 | 2003-07-22 |
| K002333 | 2000-08-31 |
Recalls
3 of these are 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 |
|---|---|---|---|---|---|
| 2015-04-17 | Class II | Software Manufacturing/Software Deployment | The Webster HIS catheter, 4Pole Fixed Curve with Auto ID, is not being recognized by the CARTO 3 navigation System. | 503 units | 2015-12-10 |
| 2015-02-25 | Class II | Device Design | Biosense Webster is recalling the LASSO NAV Duo Loop eco Catheters because of reports of difficulty retracting and damage to the spine cover. | 464 units | 2015-10-16 |
| 2013-06-19 | Class II | Use error | Biosense Webster is recalling the 20-Pole LASSO NAV Catheter Eco because it has been incorrectly calibrated causing them to be recognized and displayed as a 10-Pole LASSO NAV Catheter Eco by the CARTO 3 System. | 10 units | 2014-02-07 |
| 2011-05-23 | Not classified | Pending | The recall was initiated because Biosense Webster, Inc. has recently become aware that 20 electrodes catheters with Auto ID Technology are not being recognized when connected to the CARTO 3 System. | 429 units (333 in US) | 2012-10-12 |
| 2011-05-23 | Not classified | Pending | The recall was initiated because Biosense Webster, Inc. has recently become aware that 20 electrodes catheters with Auto ID Technology are not being recognized when connected to the CARTO 3 System. | 289 units (107 in US) | 2012-10-12 |
| 2011-05-23 | Not classified | Pending | The recall was initiated because Biosense Webster, Inc. has recently become aware that 20 electrodes catheters with Auto ID Technology are not being recognized when connected to the CARTO 3 System. | 382 units (24 in US) | 2012-10-12 |
| 2011-05-23 | Not classified | Pending | The recall was initiated because Biosense Webster, Inc. has recently become aware that 20 electrodes catheters with Auto ID Technology are not being recognized when connected to the CARTO 3 System. | 431units (298 in US) | 2012-10-12 |
| 2011-04-29 | Not classified | Labeling Change Control | The recall was expanded because between February and April 2011, Biosense Webster, Inc. notified customers that a voluntary Customer Notification had been Initiated due to the inaccessibility of the electronic version of the Instructions fo | 1530 units | 2012-10-12 |
| 2011-04-29 | Not classified | Labeling Change Control | The recall was expanded because between February and April 2011, Biosense Webster, Inc. notified customers that a voluntary Customer Notification had been Initiated due to the inaccessibility of the electronic version of the Instructions fo | 325 units | 2012-10-12 |
| 2008-03-25 | Not classified | Device Design | This recall was initiated after the firm received several complaints reporting issues with deflection. The catheter may become caught in the mitral valve, requiring surgical procedures, valve may be torn while trying to dislodge, unable to | 14,295 units for both products | 2012-05-03 |
| 2008-03-25 | Not classified | Device Design | This recall was initiated after the firm received several complaints reporting issues with deflection. The catheter may become caught in the mitral valve, requiring surgical procedures, valve may be torn while trying to dislodge, unable to | 14,295 units for both products | 2012-05-03 |
| 2007-12-15 | Not classified | Incorrect or no expiration date | The recall was initiated because the catheter unit was shipped with a label expiration date of 9/30/2010, which is 11 months beyond the correct expiration date of 10/31/2009. | 1 unit | 2012-05-23 |
| 2004-08-16 | Not classified | Other | Potential that product is incorrectly assembled with monel wire attached to the tip dome rather than copper wire. | 848 | 2005-03-31 |
| 2004-07-16 | Not classified | Other | Generator Failure resulting increase of catheter temperature that could not be controlled by power reduction. | unknown, not stated. | 2012-05-07 |
| 2004-05-21 | Not classified | Other | Mislabeling. | 212 | 2005-03-31 |
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.