Arrow
Temporary Pacing Catheter with Shrouded Pins/Introducer Kit
5manufacturers in China registered for this device type
18catalogue 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 | Teleflex Medical LLC, 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, Complaint-file establishment, Manufacturer |
| 510(k) | K945229 |
| Record published | 2016-09-16 |
| Record revised | 2023-03-03 (version 11) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Store at normal room temperature away from direct exposure to light. Prolonged exposure to fluorescent light, sunlight o |
| Packaging | Case of 5, box |
| Sizes | Catheter gauge 5 to 6 Fr; length 105 to 110 cm; catheter length 105 to 110 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPN000093 | Length 105 cm | In distribution |
| IPN919940 | In distribution | |
| IPN919926 | Catheter Length 110 cm | In distribution |
| IPN926114 | In distribution | |
| IPN919930 | Catheter Gauge 6 Fr | In distribution |
| IPN000096 | Length 110 cm | In distribution |
| IPN000044 | Catheter Gauge 6 Fr | In distribution |
| IPN000097 | Catheter Gauge 5 Fr | In distribution |
| IPN919934 | Catheter Gauge 5 Fr | In distribution |
| IPN000043 | Length 110 cm | In distribution |
| IPN000043 | Length 110 cm | In distribution |
| IPN919939 | In distribution | |
| IPN919932 | In distribution | |
| IPN926112 | In distribution | |
| IPN001009 | Length 110 cm | In distribution |
| IPN919937 | Catheter Gauge 5 Fr | In distribution |
| IPN000096 | Length 110 cm | In distribution |
| IPN000037 | 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 |
| 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
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 |
|---|---|---|---|---|---|---|---|
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2018-07-30 | Class II | Error in labeling | Products are labeled with an incorrect expiration date | 7 eaches | 2019-07-11 |
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.