Orbiter™ ST
9 catalogue numbers from M0043200030, listed by Boston Scientific Corporation, United States, under Catheter, Electrode Recording, Or Probe, Electrode Recording. 5 manufacturers in China are registered for this product 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 | Boston Scientific Corporation, 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, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-09-24 |
| Record revised | 2024-12-20 (version 3) |
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 |
| Distribution end date | 2022-05-26 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M0043200030 | 2.33 mm Diameter | Withdrawn |
| M0043200100 | 7 F Diameter | Withdrawn |
| M0043200070 | 2.33 mm Diameter | Withdrawn |
| M0043200060 | 2.33 mm Diameter | Withdrawn |
| M0043200020 | 2.33 mm Diameter | Withdrawn |
| M0043200090 | 2.33 mm Diameter | Withdrawn |
| M0043200050 | 7 F Diameter | Withdrawn |
| M0043200080 | 2.33 mm Diameter | Withdrawn |
| M0043200010 | 2.33 mm Diameter | Withdrawn |
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 |
|---|---|
| K250310 | 2025-06-27 |
| K240366 | 2024-11-01 |
| K233207 | 2023-10-27 |
| K232651 | 2023-09-29 |
| K230503 | 2023-04-25 |
| K220796 | 2022-06-10 |
| K211494 | 2021-09-14 |
| K211375 | 2021-09-10 |
| K192360 | 2019-10-25 |
| K081576 | 2009-02-03 |
| K954651 | 1996-10-22 |
| K953750 | 1996-03-11 |
| K951744 | 1995-05-04 |
| K924163 | 1993-09-03 |
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 |
|---|---|---|---|---|---|
| 2014-11-20 | Class II | Device Design | Some IntellaMap Orion High Resolution Mapping Catheters are exhibiting a failure mode in which a glue bond on the Deployment Interlock Button has been observed to fail in the field. | 184 units | 2016-08-11 |
| 2008-02-14 | Not classified | Nonconforming Material/Component | Package sterile barrier may be breached, compromising sterility. | 827 units total | 2011-01-08 |
| 2008-02-14 | Not classified | Nonconforming Material/Component | Package sterile barrier may be breached, compromising sterility. | 827 units total | 2011-01-08 |
| 2007-06-26 | Not classified | Labeling mix-ups | Product is mislabeled as hexapolar (6 electrodes), but is actually quadripolar (4 electrodes). | 30 units | 2007-11-27 |
| 2005-02-18 | Not classified | Other | The device has the potential for overheating its transformer and has the potential for fire hazard. | 2006-01-30 |
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.