Data / Medical devices / United States / Boston Scientific Cardiac Diagnostic Technologies, Inc.
Boston Scientific Cardiac Diagnostic Technologies, Inc.: FDA-registered device maker in Rochester, MN, United States, 1 510(k) clearance
Boston Scientific Cardiac Diagnostic Technologies, Inc. is registered with the FDA (registration 3009883402) in Rochester, MN, United States. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 23, 2026. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3009883402
- Address
- 2900 37th Street NW, Building 003, Rochester, MN, United States, 55901
- Owner or operator
- Boston Scientific Corporation (9912058)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- October 28, 2021
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Detector And Alarm, Arrhythmia | DSI | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Electrode, Electrocardiograph | DRX | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Electrode, Electrocardiograph, Multi-Function | MLN | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Outpatient Cardiac Telemetry | QYX | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 23, 2026 | K243349 | BodyGuardian Remote Monitoring System (BGRMS v3.0) | DSI | Substantially Equivalent | Boston Scientific Cardiac Diagnostic Technologies, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Outpatient Cardiac Telemetry
- All makers of Detector And Alarm, Arrhythmia
- All makers of Electrode, Electrocardiograph, Multi-Function
- All makers of Electrode, Electrocardiograph
Updated January 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.