Map-iT
Fixed 4/3.3F tapered, 10 electrode, S, 2-10-2mm electrode spacing, Guidewire Tip
5manufacturers in China registered for this device type
420catalogue 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 | Access Point 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 |
| 510(k) | K160390 |
| Record published | 2018-10-20 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Sizes | Length 65 to 120 cm; catheter gauge 4 to 7 Fr |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 901447 | Catheter Gauge 6 Fr | In distribution |
| 901141 | Catheter Gauge 6 Fr | In distribution |
| 901534 | Catheter Gauge 6 Fr | In distribution |
| 903257 | Catheter Gauge, 4 – 3.3 French Tapered | In distribution |
| 901709 | Catheter Gauge 6 Fr | In distribution |
| 903256 | Inter-Electrode Spacing, 2-8-2 Millimeters | In distribution |
| 901443 | Catheter Gauge 5 Fr | In distribution |
| 901104 | Catheter Gauge 5 Fr | In distribution |
| 903273 | Inter-Electrode Spacing, 2-5-2 Millimeters | In distribution |
| 901665 | Catheter Gauge 6 Fr | In distribution |
| 901880 | Catheter Gauge 5 Fr | In distribution |
| 901451 | Catheter Gauge 6 Fr | In distribution |
| 901108 | Catheter Gauge 5 Fr | In distribution |
| 901567 | Catheter Gauge 4 Fr | In distribution |
| 903731 | Catheter Gauge 5 Fr | In distribution |
| 901132 | Catheter Gauge 6 Fr | In distribution |
| 903221 | Catheter Gauge, 4 – 3.3 French Tapered | In distribution |
| 903618 | Catheter Gauge 4 Fr | In distribution |
| 901614 | Catheter Gauge 6 Fr | In distribution |
| 903313 | Catheter Gauge 4 Fr | In distribution |
| 901106 | Catheter Gauge 5 Fr | In distribution |
| 901833 | Catheter Gauge 6 Fr | In distribution |
| 901575 | Catheter Gauge 4 Fr | In distribution |
| 903220 | Length 75 cm | In distribution |
| 903830 | Catheter Gauge 6 Fr | In distribution |
| 903308 | Catheter Gauge 4 Fr | In distribution |
| 901539 | Catheter Gauge 6 Fr | In distribution |
| 901166 | Catheter Gauge 4 Fr | In distribution |
| 901878 | Catheter Gauge 6 Fr | In distribution |
| 901664 | Catheter Gauge 6 Fr | In distribution |
| 901722 | Catheter Gauge 4 Fr | In distribution |
| 901891 | Catheter Gauge 6 Fr | In distribution |
| 901645 | Inter-Electrode Spacing, 7 Millimeters | In distribution |
| 901458 | Catheter Gauge 6 Fr | In distribution |
| 901462 | Catheter Gauge 6 Fr | In distribution |
| 901481 | Catheter Gauge 4 Fr | In distribution |
| 901685 | Catheter Gauge 7 Fr | In distribution |
| 901717 | Catheter Gauge 7 Fr | In distribution |
| 903610 | Catheter Gauge 4 Fr | In distribution |
| 901784 | Catheter Gauge 5 Fr | In distribution |
| 901892 | Catheter Gauge 6 Fr | In distribution |
| 901681 | Catheter Gauge 7 Fr | In distribution |
| 901560 | Catheter Gauge 4 Fr | In distribution |
| 901533 | Catheter Gauge 6 Fr | In distribution |
| 903706 | Catheter Gauge 5 Fr | In distribution |
| 901135 | Catheter Gauge 6 Fr | In distribution |
| 901524 | Catheter Gauge 5 Fr | In distribution |
| 901138 | Catheter Gauge 6 Fr | In distribution |
| 903218 | Length 75 cm | In distribution |
| 901587 | Catheter Gauge 5 Fr | In distribution |
| 903907 | Catheter Gauge 7 Fr | In distribution |
| 901598 | Catheter Gauge 5 Fr | In distribution |
| 903269 | Catheter Gauge, 4 – 3.3 French Tapered | In distribution |
| 901461 | Catheter Gauge 6 Fr | In distribution |
| 901527 | Catheter Gauge 5 Fr | In distribution |
| 901164 | Catheter Gauge 4 Fr | In distribution |
| 903922 | Catheter Gauge 7 Fr | In distribution |
| 901799 | Catheter Gauge 6 Fr | In distribution |
| 901654 | Catheter Gauge 5 Fr | In distribution |
| 903803 | Catheter Gauge 6 Fr | In distribution |
| 901459 | Catheter Gauge 6 Fr | In distribution |
| 903838 | Catheter Gauge 6 Fr | In distribution |
| 901540 | Catheter Gauge 6 Fr | In distribution |
| 901438 | Catheter Gauge 5 Fr | In distribution |
| 901718 | Inter-Electrode Spacing, 2-8-2-8-2-8-2-8-2 Millimeters | In distribution |
| 901724 | Catheter Gauge 4 Fr | In distribution |
| 903805 | Catheter Gauge 6 Fr | In distribution |
| 901672 | Catheter Gauge 6 Fr | In distribution |
| 901107 | Catheter Gauge 5 Fr | In distribution |
| 901834 | Catheter Gauge 6 Fr | In distribution |
| 901440 | Catheter Gauge 5 Fr | In distribution |
| 901544 | Catheter Gauge 6 Fr | In distribution |
| 901476 | Catheter Gauge 4 Fr | In distribution |
| 901876 | Catheter Gauge 6 Fr | In distribution |
| 901840 | Catheter Gauge 6 Fr | In distribution |
| 901140 | Catheter Gauge 6 Fr | In distribution |
| 901173 | Catheter Gauge 4 Fr | In distribution |
| 901115 | Catheter Gauge 5 Fr | In distribution |
| 901477 | Catheter Gauge 4 Fr | In distribution |
| 901581 | Catheter Gauge 5 Fr | In distribution |
| 901797 | Catheter Gauge 5 Fr | In distribution |
| 901472 | Catheter Gauge 4 Fr | In distribution |
| 901597 | Catheter Gauge 5 Fr | In distribution |
| 901579 | Inter-Electrode Spacing, 4-4-4-23-4-4-4-4-4 Millimeters | In distribution |
| 901829 | Catheter Gauge 6 Fr | In distribution |
| 901825 | Catheter Gauge 6 Fr | In distribution |
| 901702 | Catheter Gauge 5 Fr | In distribution |
| 901570 | Catheter Gauge 4 Fr | In distribution |
| 901662 | Catheter Gauge 6 Fr | In distribution |
| 903736 | Catheter Gauge 5 Fr | In distribution |
| 903703 | Catheter Gauge 5 Fr | In distribution |
| 901143 | Catheter Gauge 6 Fr | In distribution |
| 901823 | Catheter Gauge 7 Fr | In distribution |
| 903604 | Inter-Electrode Spacing, 2-5-2 Millimeters | In distribution |
| 901538 | Catheter Gauge 6 Fr | In distribution |
| 901541 | Catheter Gauge 6 Fr | In distribution |
| 903841 | Catheter Gauge 6 Fr | In distribution |
| 901673 | Inter-Electrode Spacing, 2-8-2 Millimeters | In distribution |
| 903740 | Catheter Gauge 5 Fr | In distribution |
| 901146 | Catheter Gauge 6 Fr | In distribution |
| 901523 | Catheter Gauge 5 Fr | In distribution |
| 901482 | Catheter Gauge 4 Fr | In distribution |
| 901445 | Catheter Gauge 6 Fr | In distribution |
| 901789 | Catheter Gauge 6 Fr | In distribution |
| 901705 | Catheter Gauge 5 Fr | In distribution |
| 901452 | Catheter Gauge 6 Fr | In distribution |
| 901588 | Catheter Gauge 5 Fr | In distribution |
| 901791 | Catheter Gauge 6 Fr | In distribution |
| 901670 | Catheter Gauge 6 Fr | In distribution |
| 901592 | Catheter Gauge 5 Fr | In distribution |
| 903733 | Catheter Gauge 5 Fr | In distribution |
| 901887 | Catheter Gauge 5 Fr | In distribution |
| 901518 | Catheter Gauge 5 Fr | In distribution |
| 901593 | Catheter Gauge 5 Fr | In distribution |
| 903734 | Catheter Gauge 5 Fr | In distribution |
| 903921 | Catheter Gauge 7 Fr | In distribution |
| 901783 | Catheter Gauge 5 Fr | In distribution |
| 901893 | Catheter Gauge 6 Fr | In distribution |
| 903606 | Catheter Gauge 4 Fr | In distribution |
| 903807 | Catheter Gauge 6 Fr | In distribution |
| 901698 | Catheter Gauge 5 Fr | In distribution |
| 903214 | Length 75 cm | In distribution |
| 901701 | Catheter Gauge 5 Fr | In distribution |
| 901484 | Catheter Gauge 4 Fr | In distribution |
| 901663 | Catheter Gauge 6 Fr | In distribution |
| 901171 | Catheter Gauge 4 Fr | In distribution |
| 903836 | Catheter Gauge 6 Fr | In distribution |
| 903842 | Catheter Gauge 6 Fr | In distribution |
| 903902 | Catheter Gauge 7 Fr | In distribution |
| 901433 | Catheter Gauge 5 Fr | In distribution |
| 901600 | Catheter Gauge 5 Fr | In distribution |
| 901832 | Catheter Gauge 6 Fr | In distribution |
| 901835 | Catheter Gauge 6 Fr | In distribution |
| 903800 | Catheter Gauge 6 Fr | In distribution |
| 901144 | Catheter Gauge 6 Fr | In distribution |
| 901454 | Catheter Gauge 6 Fr | In distribution |
| 903952 | Catheter Gauge 7 Fr | In distribution |
| 901667 | Catheter Gauge 6 Fr | In distribution |
| 901721 | Catheter Gauge 4 Fr | In distribution |
| 901714 | Catheter Gauge 6 Fr | In distribution |
| 901612 | Catheter Gauge 6 Fr | In distribution |
| 901133 | Catheter Gauge 6 Fr | In distribution |
| 901470 | Catheter Gauge 4 Fr | In distribution |
| 901712 | Catheter Gauge 6 Fr | In distribution |
| 901478 | Catheter Gauge 4 Fr | In distribution |
| 901613 | Catheter Gauge 6 Fr | In distribution |
| 903833 | Catheter Gauge 6 Fr | In distribution |
| 901130 | Catheter Gauge 6 Fr | In distribution |
| 901839 | Catheter Gauge 6 Fr | In distribution |
| 901890 | Catheter Gauge 6 Fr | In distribution |
| 903226 | Catheter Gauge, 4 – 3.3 French Tapered | In distribution |
| 901522 | Catheter Gauge 5 Fr | In distribution |
| 901790 | Catheter Gauge 6 Fr | In distribution |
| 901113 | Catheter Gauge 5 Fr | In distribution |
| 903739 | Catheter Gauge 5 Fr | In distribution |
| 901537 | Catheter Gauge 6 Fr | In distribution |
| 903704 | Catheter Gauge 5 Fr | In distribution |
| 901661 | Catheter Gauge 6 Fr | In distribution |
| 903741 | Catheter Gauge 5 Fr | In distribution |
| 903620 | Catheter Gauge 4 Fr | In distribution |
| 901584 | Catheter Gauge 5 Fr | In distribution |
| 903914 | Catheter Gauge 7 Fr | In distribution |
| 901136 | Catheter Gauge 6 Fr | In distribution |
| 901675 | Catheter Gauge 6 Fr | In distribution |
| 901582 | Catheter Gauge 5 Fr | In distribution |
| 901651 | Catheter Gauge 5 Fr | In distribution |
| 903700 | Catheter Gauge 5 Fr | In distribution |
| 901456 | Catheter Gauge 6 Fr | In distribution |
| 903915 | Catheter Gauge 7 Fr | In distribution |
| 901710 | Catheter Gauge 6 Fr | In distribution |
| 903611 | Catheter Gauge 4 Fr | In distribution |
| 901580 | Catheter Gauge 5 Fr | In distribution |
| 901103 | Catheter Gauge 5 Fr | In distribution |
| 901572 | Catheter Gauge 4 Fr | In distribution |
| 901644 | Catheter Gauge 7 Fr | In distribution |
| 901699 | Catheter Gauge 6 Fr | In distribution |
| 901824 | Inter-Electrode Spacing, 4-4-4-29-4-4-4-4-4 Millimeters | In distribution |
| 901826 | Catheter Gauge 6 Fr | In distribution |
| 901422 | Catheter Gauge 5 Fr | In distribution |
| 901601 | Catheter Gauge 5 Fr | In distribution |
| 901788 | Catheter Gauge 6 Fr | In distribution |
| 903809 | Catheter Gauge 6 Fr | In distribution |
| 901448 | Catheter Gauge 6 Fr | In distribution |
| 903839 | Catheter Gauge 6 Fr | In distribution |
| 903710 | Catheter Gauge 5 Fr | In distribution |
| 901884 | Catheter Gauge 5 Fr | In distribution |
| 901704 | Catheter Gauge 5 Fr | In distribution |
| 903919 | Catheter Gauge 7 Fr | In distribution |
| 901599 | Catheter Gauge 5 Fr | In distribution |
| 901843 | Catheter Gauge 6 Fr | In distribution |
| 901112 | Catheter Gauge 5 Fr | In distribution |
| 903911 | Catheter Gauge 7 Fr | In distribution |
| 903602 | Catheter Gauge 4 Fr | In distribution |
| 903254 | Length 75 cm | In distribution |
| 903217 | Catheter Gauge, 4 – 3.3 French Tapered | In distribution |
| 901792 | Catheter Gauge 5 Fr | In distribution |
| 901642 | Catheter Gauge 7 Fr | In distribution |
| 901837 | Catheter Gauge 6 Fr | In distribution |
| 903616 | Catheter Gauge 4 Fr | In distribution |
| 903711 | Catheter Gauge 5 Fr | In distribution |
| 903708 | Catheter Gauge 5 Fr | In distribution |
| 901785 | Catheter Gauge 5 Fr | In distribution |
| 901430 | Catheter Gauge 5 Fr | In distribution |
| 901432 | Catheter Gauge 5 Fr | In distribution |
| 901101 | Catheter Gauge 5 Fr | In distribution |
| 903950 | Catheter Gauge 7 Fr | In distribution |
| 901707 | Catheter Gauge 7 Fr | In distribution |
| 901650 | Catheter Gauge 5 Fr | In distribution |
| 901530 | Catheter Gauge 5 Fr | In distribution |
| 903831 | Catheter Gauge 6 Fr | In distribution |
| 903953 | Catheter Gauge 7 Fr | In distribution |
| 901568 | Catheter Gauge 4 Fr | In distribution |
| 901531 | Catheter Gauge 5 Fr | In distribution |
| 901822 | Catheter Gauge 6 Fr | In distribution |
| 901700 | Catheter Gauge 5 Fr | In distribution |
| 903603 | Inter-Electrode Spacing, 2-5-2 Millimeters | In distribution |
| 901172 | Catheter Gauge 4 Fr | In distribution |
| 903917 | Catheter Gauge 7 Fr | In distribution |
| 901574 | Catheter Gauge 4 Fr | In distribution |
| 901453 | Catheter Gauge 6 Fr | In distribution |
| 901827 | Catheter Gauge 6 Fr | In distribution |
| 903923 | Catheter Gauge 7 Fr | In distribution |
| 901828 | Catheter Gauge 6 Fr | In distribution |
| 903701 | Catheter Gauge 5 Fr | In distribution |
| 901535 | Catheter Gauge 6 Fr | In distribution |
| 901610 | Catheter Gauge 6 Fr | In distribution |
| 901786 | Catheter Gauge 6 Fr | In distribution |
| 903608 | Catheter Gauge 4 Fr | In distribution |
| 901571 | Catheter Gauge 4 Fr | In distribution |
| 901175 | Catheter Gauge 4 Fr | In distribution |
| 903735 | Catheter Gauge 5 Fr | In distribution |
| 903904 | Catheter Gauge 7 Fr | In distribution |
| 903707 | Catheter Gauge 5 Fr | In distribution |
| 903307 | Catheter Gauge 4 Fr | In distribution |
| 901830 | Catheter Gauge 6 Fr | In distribution |
| 901703 | Catheter Gauge 5 Fr | In distribution |
| 903600 | Catheter Gauge 4 Fr | In distribution |
| 901161 | Catheter Gauge 4 Fr | In distribution |
| 901139 | Catheter Gauge 6 Fr | In distribution |
| 903801 | Catheter Gauge 6 Fr | In distribution |
| 901881 | Catheter Gauge 5 Fr | In distribution |
| 901782 | Catheter Gauge 5 Fr | In distribution |
| 903621 | Catheter Gauge 4 Fr | In distribution |
| 903738 | Catheter Gauge 5 Fr | In distribution |
| 901174 | Catheter Gauge 4 Fr | In distribution |
| 901475 | Catheter Gauge 4 Fr | In distribution |
| 901434 | Catheter Gauge 5 Fr | In distribution |
| 901165 | Catheter Gauge 4 Fr | In distribution |
| 901713 | Catheter Gauge 6 Fr | In distribution |
| 903709 | Catheter Gauge 5 Fr | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| AcQRate Dx Fixed Curve Catheter | VascoMed GmbH | 20 |
Showing 12 of 112. All products under Catheter, Electrode Recording, Or Probe, Electrode Recording
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.