Supreme™
55 catalogue numbers from 401877, listed by St. Jude Medical Cardiovascular Division, 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
55catalogue 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) | K894500 |
| Record published | 2015-04-22 |
| Record revised | 2020-11-17 (version 4) |
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, manufacturing date |
| Storage | Special storage condition: STORE IN A COOL,DARK,DRY PLACE. Protect from radioactive sources. |
| Sizes | Catheter gauge 4 to 6 Fr |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 401877 | Catheter Gauge 6 Fr | In distribution |
| 402010 | Catheter Gauge 6 Fr | In distribution |
| 402020 | Catheter Gauge 6 Fr | In distribution |
| 401996 | Catheter Gauge 4 Fr | In distribution |
| 401864 | Catheter Gauge 5 Fr | In distribution |
| 401470 | Catheter Gauge 6 Fr | In distribution |
| 401952 | Catheter Gauge 6 Fr | In distribution |
| 401474 | Catheter Gauge 6 Fr | In distribution |
| 401893 | Catheter Gauge 4 Fr | In distribution |
| 401466 | Catheter Gauge 5 Fr | In distribution |
| 401967 | Catheter Gauge 4 Fr | In distribution |
| 401993 | Catheter Gauge 4 Fr | In distribution |
| 401438 | Catheter Gauge 6 Fr | In distribution |
| 401871 | Catheter Gauge 5 Fr | In distribution |
| 401453 | Catheter Gauge 6 Fr | In distribution |
| 401957 | Catheter Gauge 5 Fr | In distribution |
| 401890 | Catheter Gauge 4 Fr | In distribution |
| 401449 | Catheter Gauge 6 Fr | In distribution |
| 401878 | Catheter Gauge 5 Fr | In distribution |
| 401865 | Catheter Gauge 5 Fr | In distribution |
| 402004 | Catheter Gauge 6 Fr | In distribution |
| 401475 | Catheter Gauge 6 Fr | In distribution |
| 401448 | Catheter Gauge 5 Fr | In distribution |
| 401860 | Catheter Gauge 5 Fr | In distribution |
| 401968 | Catheter Gauge 4 Fr | In distribution |
| 401435 | Catheter Gauge 5 Fr | In distribution |
| 401450 | Catheter Gauge 5 Fr | In distribution |
| 401876 | Catheter Gauge 6 Fr | In distribution |
| 401979 | Catheter Gauge 4 Fr | In distribution |
| 401468 | Catheter Gauge 5 Fr | In distribution |
| 401994 | Catheter Gauge 4 Fr | In distribution |
| 401859 | Catheter Gauge 5 Fr | In distribution |
| 402012 | Catheter Gauge 4 Fr | In distribution |
| 401444 | Catheter Gauge 5 Fr | In distribution |
| 401862 | Catheter Gauge 5 Fr | In distribution |
| 401441 | Catheter Gauge 5 Fr | In distribution |
| 401891 | Catheter Gauge 4 Fr | In distribution |
| 401451 | Catheter Gauge 6 Fr | In distribution |
| 401443 | Catheter Gauge 5 Fr | In distribution |
| 402011 | Catheter Gauge 6 Fr | In distribution |
| 402009 | Catheter Gauge 5 Fr | In distribution |
| 401433 | Catheter Gauge 5 Fr | In distribution |
| 401951 | Catheter Gauge 6 Fr | In distribution |
| 401430 | Catheter Gauge 6 Fr | In distribution |
| 401434 | Catheter Gauge 6 Fr | In distribution |
| 401892 | Catheter Gauge 4 Fr | In distribution |
| 401445 | Catheter Gauge 6 Fr | In distribution |
| 401442 | Catheter Gauge 6 Fr | In distribution |
| 401436 | Catheter Gauge 6 Fr | In distribution |
| 401956 | Catheter Gauge 6 Fr | In distribution |
| 401872 | Catheter Gauge 5 Fr | In distribution |
| 401863 | Catheter Gauge 5 Fr | In distribution |
| 401966 | Catheter Gauge 4 Fr | In distribution |
| 402033 | Catheter Gauge 6 Fr | In distribution |
| 402008 | Catheter Gauge 5 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 |
| 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
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.