Inquiry™ AFocus II™
Diagnostic Catheter
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 |
| Record published | 2015-05-22 |
| Record revised | 2023-08-11 (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: Keep dry. Keep away from sunlight. |
| Sizes | Catheter gauge 7 Fr; length 110 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IBI-87008 | Catheter Gauge 7 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 |
| 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 |
|---|---|
| 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
2 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 |
|---|---|---|---|---|---|
| 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 |
| 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 |
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.