Data / Medical devices / Catheter, Intracardiac Mapping, High-Density Array
Catheter, Intracardiac Mapping, High-Density Array (MTD): 18 FDA-registered makers in 4 countries
18 establishments in 4 countries are registered with the FDA to make Catheter, Intracardiac Mapping, High-Density Array (product code MTD, Class 2, 21 CFR 870.1220). 8 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 34 510(k) clearances under this code, the latest on April 23, 2026, and lists 7 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- MTD
- Device class
- 2
- Regulation
- 870.1220
- Medical specialty
- Cardiovascular
Makers by country
| Country | Makers |
|---|---|
| United States | 12 |
| Mexico | 4 |
| Costa Rica | 1 |
| Taiwan | 1 |
Makers of Catheter, Intracardiac Mapping, High-Density Array
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Biosense Webster, Inc. | Irvine, CA, United States | Complaint file establishment, Specification developer | 8 | July 10, 2023 | 0 | 1 | 0 | api.fda.gov |
| Cordis de Mexico, SA de CV | JUAREZ Chihuahua, Mexico | Manufacturer | 8 | July 10, 2023 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Saint Paul, MN, United States | Complaint file establishment, Specification developer | 3 | April 23, 2026 | 0 | 0 | 0 | api.fda.gov |
| St. Jude Medical, Cardiology Division, Inc. | Plymouth, MN, United States | Complaint file establishment, Manufacturer, Specification developer | 3 | July 9, 2024 | 0 | 1 | 0 | api.fda.gov |
| Abbott Medical Costa Rica Ltda. | El Coyol Alajuela, Costa Rica | Manufacturer | 2 | July 9, 2024 | 0 | 0 | 0 | api.fda.gov |
| Cortex, Inc. | Santa Clara, CA, United States | Specification developer | 2 | March 13, 2026 | 0 | 0 | 0 | api.fda.gov |
| St. Jude Medical | Roseville, MN, United States | Manufacturer | 2 | July 9, 2024 | 0 | 0 | 0 | api.fda.gov |
| Sterilmed, Inc. | Plymouth, MN, United States | Reprocessor, Specification developer | 1 | June 23, 2021 | 0 | 0 | 0 | api.fda.gov |
| Abbott Medical Mexico, S. de R.L. de C.V. | Santa Rosa Jauregui Queretaro, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Foxconn Baja California S.A De C.V. | tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Greatbatch Medical | Minneapolis, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Innovative Health, LLC. | Scottsdale, AZ, United States | Reprocessor | 0 | 0 | 0 | 0 | api.fda.gov | |
| Intai Technology Corp. | Taichung City, Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Irvine Biomedical. Inc. | Irvine, CA, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Molex S.A. De C.V. | Nogales Sonora, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Switchback Medical | Brooklyn Park, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| St. Jude Medical, Atrial Fibrillation Division, Inc. | Saint Paul, MN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| St. Jude Medical, Atrial Fibrillation Division, Inc. | Minnetonka, MN, United States | Manufacturer, Reprocessor, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated April 23, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.