Inquiry™
Steerable Diagnostic Catheter 1110-6-2-L1-TE2BE2
5manufacturers in China registered for this device type
122catalogue numbers in this listing
11510(k) clearances naming this product code
2recalls 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 | Irvine Biomedical. 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, Manufacturer, Exporter |
| 510(k) | K042775 |
| Record published | 2015-03-27 |
| Record revised | 2020-10-22 (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, manufacturing date |
| Storage | Special storage condition: Store in a cool, dry location. |
| Sizes | Catheter gauge 4 to 7 Fr; length 95 to 110 cm |
| Distribution end date | 2017-12-18 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IBI-81590 | Catheter Gauge 7 Fr | In distribution |
| IBI-81403 | Catheter Gauge 6 Fr | In distribution |
| IBI-80452 | Catheter Gauge 5 Fr | In distribution |
| IBI-80406 | Catheter Gauge 6 Fr | In distribution |
| IBI-81207 | Catheter Gauge 7 Fr | In distribution |
| IBI-80063 | Catheter Gauge 5 Fr | In distribution |
| IBI-81767 | Catheter Gauge 7 Fr | In distribution |
| IBI-80412 | Catheter Gauge 6 Fr | In distribution |
| IBI-80003 | Catheter Gauge 6 Fr | In distribution |
| IBI-81491 | Catheter Gauge 6 Fr | In distribution |
| IBI-81918 | Catheter Gauge 7 Fr | In distribution |
| IBI-81659 | Length 110 cm | In distribution |
| IBI-81483 | Catheter Gauge 5 Fr | In distribution |
| IBI-80254 | Catheter Gauge 6 Fr | In distribution |
| IBI-81947 | Catheter Gauge 6 Fr | In distribution |
| IBI-81144 | Catheter Gauge 6 Fr | In distribution |
| IBI-81664 | Catheter Gauge 7 Fr | In distribution |
| IBI-87007 | Catheter Gauge 7 Fr | In distribution |
| IBI-81214 | Catheter Gauge 6 Fr | In distribution |
| IBI-81532 | Catheter Gauge 4 Fr | In distribution |
| IBI-81199 | Catheter Gauge 6 Fr | In distribution |
| IBI-81543 | Catheter Gauge 4 Fr | In distribution |
| IBI-81596 | Catheter Gauge 7 Fr | In distribution |
| IBI-81542 | Catheter Gauge 4 Fr | In distribution |
| IBI-81224 | Catheter Gauge 5 Fr | In distribution |
| IBI-81172 | Catheter Gauge 5 Fr | In distribution |
| IBI-81762 | Catheter Gauge 5 Fr | In distribution |
| IBI-80570 | Catheter Gauge 6 Fr | In distribution |
| IBI-80440 | Catheter Gauge 5 Fr | In distribution |
| IBI-80142 | Catheter Gauge 6 Fr | In distribution |
| IBI-81674 | Catheter Gauge 5 Fr | In distribution |
| IBI-81121 | Catheter Gauge 7 Fr | In distribution |
| IBI-81526 | Catheter Gauge 5 Fr | In distribution |
| IBI-81540 | Catheter Gauge 4 Fr | In distribution |
| IBI-80405 | Catheter Gauge 6 Fr | In distribution |
| IBI-81603 | Catheter Gauge 6 Fr | In distribution |
| IBI-81736 | Catheter Gauge 5 Fr | In distribution |
| IBI-80064 | Catheter Gauge 5 Fr | In distribution |
| IBI-81534 | Catheter Gauge 4 Fr | In distribution |
| IBI-81124 | Catheter Gauge 7 Fr | In distribution |
| IBI-81472 | Catheter Gauge 5 Fr | In distribution |
| IBI-81120 | Catheter Gauge 7 Fr | In distribution |
| IBI-81130 | Catheter Gauge 7 Fr | In distribution |
| IBI-80250 | Catheter Gauge 6 Fr | In distribution |
| IBI-81104 | Catheter Gauge 6 Fr | In distribution |
| IBI-81945 | Catheter Gauge 6 Fr | In distribution |
| IBI-81105 | Catheter Gauge 6 Fr | In distribution |
| IBI-81802 | Catheter Gauge 6 Fr | In distribution |
| IBI-81521 | Catheter Gauge 5 Fr | In distribution |
| IBI-80627 | Catheter Gauge 5 Fr | In distribution |
| IBI-81221 | Catheter Gauge 6 Fr | In distribution |
| IBI-81730 | Catheter Gauge 5 Fr | In distribution |
| IBI-81402 | Catheter Gauge 6 Fr | In distribution |
| IBI-81587 | Catheter Gauge 7 Fr | In distribution |
| IBI-81473 | Catheter Gauge 5 Fr | In distribution |
| IBI-80469 | Catheter Gauge 4 Fr | In distribution |
| IBI-80567 | Catheter Gauge 4 Fr | In distribution |
| IBI-81801 | Catheter Gauge 6 Fr | In distribution |
| IBI-81734 | Catheter Gauge 5 Fr | In distribution |
| IBI-80575 | Catheter Gauge 5 Fr | In distribution |
| IBI-81213 | Catheter Gauge 6 Fr | In distribution |
| IBI-81202 | Catheter Gauge 7 Fr | In distribution |
| IBI-81102 | Catheter Gauge 6 Fr | In distribution |
| IBI-81530 | Catheter Gauge 4 Fr | In distribution |
| IBI-81226 | Catheter Gauge 6 Fr | In distribution |
| IBI-81673 | Catheter Gauge 5 Fr | In distribution |
| IBI-80456 | Catheter Gauge 5 Fr | In distribution |
| IBI-81504 | Catheter Gauge 6 Fr | In distribution |
| IBI-81595 | Catheter Gauge 7 Fr | In distribution |
| IBI-81417 | Catheter Gauge 6 Fr | In distribution |
| IBI-80409 | Catheter Gauge 6 Fr | In distribution |
| IBI-81687 | Catheter Gauge 7 Fr | In distribution |
| IBI-81126 | Catheter Gauge 7 Fr | In distribution |
| IBI-81136 | Catheter Gauge 7 Fr | In distribution |
| IBI-81405 | Catheter Gauge 6 Fr | In distribution |
| IBI-81516 | Catheter Gauge 6 Fr | In distribution |
| D087023 | Catheter Gauge 7 Fr | In distribution |
| IBI-81223 | Catheter Gauge 5 Fr | In distribution |
| IBI-81134 | Catheter Gauge 7 Fr | In distribution |
| IBI-81171 | Catheter Gauge 5 Fr | In distribution |
| IBI-80465 | Catheter Gauge 4 Fr | In distribution |
| IBI-81520 | Catheter Gauge 6 Fr | In distribution |
| IBI-81717 | Catheter Gauge 7 Fr | In distribution |
| IBI-81209 | Catheter Gauge 7 Fr | In distribution |
| IBI-81557 | Catheter Gauge 5 Fr | In distribution |
| D087022 | Catheter Gauge 7 Fr | In distribution |
| IBI-80251 | Catheter Gauge 6 Fr | In distribution |
| IBI-81531 | Catheter Gauge 4 Fr | In distribution |
| IBI-81735 | Catheter Gauge 5 Fr | In distribution |
| IBI-80139 | Catheter Gauge 6 Fr | In distribution |
| IBI-80043 | Catheter Gauge 6 Fr | In distribution |
| IBI-81721 | Catheter Gauge 5 Fr | In distribution |
| IBI-80515 | Catheter Gauge 6 Fr | In distribution |
| IBI-81599 | Catheter Gauge 7 Fr | In distribution |
| IBI-80413 | Catheter Gauge 6 Fr | In distribution |
| IBI-81938 | Catheter Gauge 7 Fr | In distribution |
| IBI-80804 | Catheter Gauge 6 Fr | In distribution |
| D087024 | Catheter Gauge 7 Fr | In distribution |
| IBI-81474 | Catheter Gauge 5 Fr | In distribution |
| IBI-81872 | Catheter Gauge 5 Fr | In distribution |
| IBI-81174 | Catheter Gauge 5 Fr | In distribution |
| IBI-81930 | Catheter Gauge 7 Fr | In distribution |
| IBI-80453 | Catheter Gauge 5 Fr | In distribution |
| IBI-81404 | Catheter Gauge 6 Fr | In distribution |
| IBI-81125 | Catheter Gauge 7 Fr | In distribution |
| IBI-80571 | Catheter Gauge 5 Fr | In distribution |
| IBI-81920 | Catheter Gauge 7 Fr | In distribution |
| IBI-81683 | Catheter Gauge 7 Fr | In distribution |
| IBI-81107 | Catheter Gauge 6 Fr | In distribution |
| IBI-81594 | Catheter Gauge 7 Fr | In distribution |
| IBI-81807 | Catheter Gauge 6 Fr | In distribution |
| IBI-80466 | Catheter Gauge 4 Fr | In distribution |
| IBI-81680 | Catheter Gauge 5 Fr | In distribution |
| IBI-81508 | Catheter Gauge 6 Fr | In distribution |
| IBI-81809 | Catheter Gauge 6 Fr | In distribution |
| IBI-81537 | Catheter Gauge 4 Fr | In distribution |
| IBI-81418 | Catheter Gauge 6 Fr | In distribution |
| IBI-81871 | Catheter Gauge 5 Fr | In distribution |
| IBI-80468 | Catheter Gauge 4 Fr | In distribution |
| IBI-80253 | Catheter Gauge 6 Fr | In distribution |
| IBI-81524 | Catheter Gauge 6 Fr | In distribution |
| AFocus II™ | Catheter Gauge 7 Fr | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Map-iT | Access Point Medical, LLC | 420 |
| Woven | Boston Scientific Corporation | 126 |
| 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 |
| 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 |
|---|---|
| K082061 | 2008-08-19 |
| K060757 | 2006-04-19 |
| K053582 | 2006-03-21 |
| K042775 | 2004-11-04 |
| K010471 | 2001-06-06 |
| K991878 | 1999-12-10 |
| K991025 | 1999-10-15 |
| K990958 | 1999-06-03 |
| K982232 | 1998-07-25 |
| K961924 | 1997-04-11 |
| K946333 | 1995-07-18 |
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Irvine Biomedical. Inc. | UDI-DI | 2020-08-24 | Class II | Labeling mix-ups | Steerable diagnostic catheter packages labeled Model IBI-81104, batch 7397352 incorrectly contained Model IBI-87002, batch 7397307. Packages labeled Model IBI-87002, batch 7397307 incorrectly contained Model IBI-81104, batch 7397352.If phys | 15 units | 2023-07-31 |
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 |
|---|---|---|---|---|---|
| 2020-08-24 | Class II | Labeling mix-ups | Steerable diagnostic catheter packages labeled Model IBI-81104, batch 7397352 incorrectly contained Model IBI-87002, batch 7397307. Packages labeled Model IBI-87002, batch 7397307 incorrectly contained Model IBI-81104, batch 7397352.If phys | 40 units | 2023-07-31 |
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.