Data / Medical devices / United States / Biosense Webster, Inc.
Biosense Webster, Inc.: FDA-registered device maker in Irvine, CA, United States, 8 510(k) clearances
Biosense Webster, Inc. is registered with the FDA (registration 3022451073) in Irvine, CA, United States. It lists 1 device type. The FDA files 8 510(k) clearances under its listings, the newest dated February 20, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3022451073
- Address
- 23 Hubble Drive, Irvine, CA, United States, 92618
- Owner or operator
- BIOSENSE WEBSTER, INC. (9044811)
- Roles
- Manufacturer
- First device listed
- August 9, 2017
- Registered through
- 2027
- Brand names listed
- CARTO 3 EP Navigation System V8.4, CARTO 3 EP Navigation System Version 7.2, CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM), CARTO 3 EP Navigation System, Version 6, CARTO 3 System and Accessories, version 4.3.5 with Coherent Mapping, CARTO 3 System v6 with VISITAG SURPPOINT, CARTO 3 system version 8, CARTO 3 EP Navigation System V8.1
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Computer, Diagnostic, Programmable | DQK | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| February 20, 2026 | K252972 | CARTO 3 EP Navigation System V8.4 | DQK | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| August 22, 2025 | K252302 | CARTO 3 EP Navigation System V8.1 | DQK | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| September 7, 2023 | K231207 | CARTO 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U) | DQK | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| August 17, 2022 | K221112 | CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM) | DQK | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| October 29, 2021 | K213264 | CARTO 3 EP Navigation System Version 7.2 | DQK | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| June 14, 2018 | K173977 | CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP Module | DQK | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| June 1, 2018 | K180238 | CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINT | DQK | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| July 25, 2017 | K170600 | CARTO 3 EP Navigation System, Version 6.0 and Accessories | DQK | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
Compare with other makers
Updated February 20, 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.