Response™
Electrophysiology Catheter with Lumen
5manufacturers in China registered for this device type
46catalogue numbers in this listing
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 | St. Jude Medical Cardiovascular Division |
|---|---|
| FDA product code | DRF |
| Device type | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1220 |
| 510(k) | K914278 |
| Record published | 2015-05-12 |
| Record revised | 2023-10-30 (version 5) |
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 |
| Storage | Special storage condition: STORE AWAY FROM RADIOACTIVE SOURCES. STORE IN A COOL, DARK, DRY PLACE. |
| Sizes | Catheter gauge 5 to 7 Fr |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 401133 | Catheter Gauge 7 Fr | In distribution |
| 401226 | Catheter Gauge 6 Fr | In distribution |
| 401210 | Catheter Gauge 6 Fr | In distribution |
| 401310 | Catheter Gauge 6 Fr | In distribution |
| 401260 | Catheter Gauge 6 Fr | In distribution |
| 401134 | Catheter Gauge 7 Fr | In distribution |
| 401357 | Catheter Gauge 6 Fr | In distribution |
| 401360 | Catheter Gauge 5 Fr | In distribution |
| 401222 | Catheter Gauge 5 Fr | In distribution |
| 401400 | Catheter Gauge 6 Fr | In distribution |
| 401223 | Catheter Gauge 5 Fr | In distribution |
| 401152 | Catheter Gauge 6 Fr | In distribution |
| 401392 | Catheter Gauge 6 Fr | In distribution |
| 401312 | Catheter Gauge 6 Fr | In distribution |
| 401228 | Catheter Gauge 6 Fr | In distribution |
| 401227 | Catheter Gauge 6 Fr | In distribution |
| 401158 | Catheter Gauge 6 Fr | In distribution |
| 401137 | Catheter Gauge 7 Fr | In distribution |
| 401308 | Catheter Gauge 6 Fr | In distribution |
| 401261 | Catheter Gauge 6 Fr | In distribution |
| 401311 | Catheter Gauge 6 Fr | In distribution |
| 401282 | Catheter Gauge 6 Fr | In distribution |
| 401305 | Catheter Gauge 6 Fr | In distribution |
| 401156 | Catheter Gauge 6 Fr | In distribution |
| 401211 | Catheter Gauge 6 Fr | In distribution |
| 401150 | Catheter Gauge 6 Fr | In distribution |
| 401155 | Catheter Gauge 6 Fr | In distribution |
| 401353 | Catheter Gauge 6 Fr | In distribution |
| 401399 | Catheter Gauge 6 Fr | In distribution |
| 401212 | Catheter Gauge 6 Fr | In distribution |
| 401306 | Catheter Gauge 6 Fr | In distribution |
| 401130 | Catheter Gauge 7 Fr | In distribution |
| 401206 | Catheter Gauge 5 Fr | In distribution |
| 401132 | Catheter Gauge 7 Fr | In distribution |
| 401309 | Catheter Gauge 6 Fr | In distribution |
| 401381 | Catheter Gauge 6 Fr | In distribution |
| 401271 | Catheter Gauge 6 Fr | In distribution |
| 401386 | Catheter Gauge 6 Fr | In distribution |
| 401275 | Catheter Gauge 6 Fr | In distribution |
| 401318 | Catheter Gauge 6 Fr | In distribution |
| 401207 | Catheter Gauge 5 Fr | In distribution |
| 401278 | Catheter Gauge 6 Fr | In distribution |
| 401317 | Catheter Gauge 6 Fr | In distribution |
| 401276 | Catheter Gauge 6 Fr | In distribution |
| 401356 | Catheter Gauge 6 Fr | In distribution |
| 401154 | Catheter Gauge 6 Fr | 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 |
| 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
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 |
|---|---|---|---|---|---|---|---|
| St. Jude Medical | 510(k) number | 2014-10-14 | Class II | Labeling mix-ups | St. Jude Medical is performing a voluntary recall of batch 4671318, model number 401353 of the Response Fixed Curve DECA 6F 65cm CSL 2/8 Catheter. Specifically, the firm has identified that every device packaged within batch 4671318 contain | 26 | 2014-12-10 |
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.