510(k) K252302
- Device
- CARTO 3 EP Navigation System V8.1
- Applicant
- Biosense Webster, Inc.
- 510(k) number
- K252302
- Product code
- DQK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-08-22
- Date received
- 2025-07-24
- Regulation
- 870.1425
- Classification name
- Computer, Diagnostic, Programmable
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Caleb Lau
- Address
- 31 Technology Dr., Suite 200 Irvine CA US 92618 92618
FDA Registration Numbers
- 2184149
- 3005877899
- 9710602
- 1218950
- 3007603855
- 3032109181
- 3013627970
- 3001592626
- 1054713
- 3004972322
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- 2029275
- 1651104
- 3012154226
- 3024821700
- 1000122786
- 1317188
- 2124215
- 3008012314
- 2952596
- 3012179728
- 3001763079
- 8030978
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Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Other 510(k) Records For Product Code DQK
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|---|---|---|---|
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| K253186 | HemoSphere Nano Monitor (HSNANO1) | Edwards Lifesciences, LLC | 2026-02-24 |
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| K252533 | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) | Edwards Lifesciences | 2025-12-18 |
| K253141 | DeepRhythmAI | Medicalgorithmics S.A. | 2025-12-11 |
| K252429 | Vektor Computational ECG Mapping System (vMap®) | Vektor Medical, Inc. | 2025-12-04 |
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