Carto 3
13 catalogue numbers from D129704, listed by Biosense Webster, Inc., United States, under Computer, Diagnostic, Programmable. 10 manufacturers in China are registered for this product code.
10manufacturers in China registered for this device type
13catalogue numbers in this listing
34510(k) clearances naming this product code
7recalls on this code
Who Else Makes It
Concentrated in Guangdong (7), Shanghai (2), Jiangsu (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Jabil Circuit (Shanghai) Ltd. | Shanghai | Shanghai | Contract manufacturer | 31 |
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Dongguan Ergotron Precision Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 2 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Shenzhen BelterHealthMeasurementAndAnalysisTechnologyCo.,Ltd | Shenzhen | Guangdong | Manufacturer | 7 |
| Philips (China) Investment Co., Ltd. Philips Healthcare – Shanghai CDC | Shanghai | Shanghai | Specification developer | 6 |
| Shenzhen Carewell Electronics Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 2 |
Record
| Listed by | Biosense Webster, Inc., United States |
|---|---|
| FDA product code | DQK |
| Device type | Computer, Diagnostic, Programmable |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1425 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K090017 |
| Record published | 2016-09-16 |
| Record revised | 2026-05-22 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization, Ethylene Oxide |
| Supplied sterile | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep out of direct sunlight; Special storage condition: Keep Dry; Storage environment temperature 41 to 77 °F; Storage environment temperature 5 to 25 °C; Special storage condition: Do not use if package is damaged |
| Distribution end date | 2023-06-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| D129704 | In distribution | |
| CB3410CT | In distribution | |
| D129707 | In distribution | |
| CY1212CT | In distribution | |
| CY1210CT | In distribution | |
| CG2025CT | In distribution | |
| CR3425CT | In distribution | |
| D128622 | In distribution | |
| CB3434CT | In distribution | |
| CR3434CT | In distribution | |
| CB3412CT | In distribution | |
| D128624 | In distribution | |
| D128627 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| EnSite™ | St. Jude Medical | 177 |
| Computer, Diagnostic, Programmable | St. Jude Medical | 57 |
| MediGuide™ | St. Jude Medical | 41 |
| AcQMap | Acutus Medical, Inc. | 38 |
| WorkMate Claris™ | St. Jude Medical | 35 |
| iLab Ultrasound Imaging System | Boston Scientific Corporation | 32 |
| Rhythmia™ Mapping System | Boston Scientific Corporation | 31 |
| Sentinel | Spacelabs Healthcare (Washington), Inc | 28 |
| Rhythmia HDx™ | Boston Scientific Corporation | 26 |
| EnSite Precision™ | St. Jude Medical | 23 |
| PathfinderSL | Spacelabs Healthcare (Washington), Inc | 22 |
| Labsystem™ PRO | Boston Scientific Corporation | 19 |
Showing 12 of 228. All products under Computer, Diagnostic, Programmable
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K252972 | 2026-02-20 |
| K254085 | 2026-01-18 |
| K252302 | 2025-08-22 |
| K231207 | 2023-09-07 |
| K223733 | 2023-02-16 |
| K221112 | 2022-08-17 |
| K213264 | 2021-10-29 |
| K200484 | 2020-11-25 |
| K191660 | 2019-07-20 |
| K173978 | 2018-08-24 |
| K173977 | 2018-06-14 |
| K180238 | 2018-06-01 |
| K170600 | 2017-07-25 |
| K133916 | 2014-07-01 |
| K132782 | 2014-01-24 |
| K120550 | 2012-05-07 |
| K112007 | 2011-10-05 |
| K103746 | 2011-01-21 |
| K093566 | 2010-06-18 |
| K093455 | 2009-12-04 |
| K090017 | 2009-10-13 |
| K091789 | 2009-10-01 |
| K072202 | 2007-11-19 |
| K070240 | 2007-05-04 |
| K053194 | 2006-03-09 |
| K042681 | 2005-09-29 |
| K042999 | 2005-03-21 |
| K020863 | 2003-01-09 |
| K013083 | 2001-11-21 |
| K000190 | 2000-05-05 |
| K000248 | 2000-05-05 |
| K000332 | 2000-05-04 |
| K993729 | 1999-12-03 |
| K992968 | 1999-09-29 |
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Biosense Webster, Inc. | 510(k) number | 2012-02-09 | Not classified | Nonconforming Material/Component | Some CARTO 3 Systems may get radio frequency interference through certain interconnected cable configurations resulting in jumping or disappearing catheter icon and/or error messages during ablation. | 134 units total (32 units in US) | 2012-09-06 |
| Biosense Webster, Inc. | 510(k) number | 2011-02-15 | Not classified | Other | The recall was initiated because Biosense Webster has confirmed that there is an inaccessibility of electronic version of the instruction for use (e-IFU) for the “10 ft. Interface Cable, 10 Pin-Shielded Tip Pins to 12 Pin-Blue”, catalog num | 606 units total | 2012-05-07 |
| Biosense Webster, Inc. | 510(k) number | 2009-11-17 | Class II | Labeling mix-ups | The recall was initiated because Biosense Webster has become aware of information regarding a potential hazard that may occur during the operation of a Bloom EP Stimulator device in conjunction with RF generators and other electrophysiology | 71 units total (30 units in US) | 2012-09-12 |
Recalls
4 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 |
|---|---|---|---|---|---|
| 2016-08-15 | Class II | Under Investigation by firm | Biosense Webster, Inc. is initiating a voluntary correction to re-install identified CARTO 3 Systems that were moved and installed in China without testing and approval by Biosense Webster Technical Services, as described in the Instruction | 338 units | 2017-01-20 |
| 2015-09-10 | Class II | Device Design | Image disappeared from the cardiac ultrasound system when the CARTO 3 EP Navigation System needed restarting while the patient was experiencing pericardial effusion. Affects the CARTOSOUND Module of the CARTO 3 EP Navigation System when us | 1035 (U.S.) | 2016-05-13 |
| 2014-02-12 | Class II | Other | Biosense Webster has initiated a recall of the CartoUnivu Module within the Carto 3 System (V3.2.2 and V3.2.3) when used with Siemens Axiom Artis VB Fluoroscopy systems in particular procedural configurations only. If the table rotation i | 8 units total (5 units in US) | 2014-05-23 |
| 2013-03-05 | Class II | Employee error | Biosense is recalling the 20-Pole Eco Cable because it was incorrectly calibrated. When a catheter is connected to an affected to an affected 20-Pole Eco Cable, the catheter will not be recognized by the impacted 54 cable serial numbers wi | 54 units | 2013-10-17 |
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.