DQK — Computer, Diagnostic, Programmable Class II
FDA Device Classification
Classification Details
- Product Code
- DQK
- Device Class
- Class II
- Regulation Number
- 870.1425
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K253186 | edwards lifesciences | HemoSphere Nano Monitor (HSNANO1) | February 24, 2026 |
| K252972 | biosense webster | CARTO 3 EP Navigation System V8.4 | February 20, 2026 |
| K254089 | centerline biomedical | IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751 | February 17, 2026 |
| K251591 | edan instruments | Holter ECG and ABP system (HolterABP) | February 9, 2026 |
| K251218 | safebeat rx | SafeBeat Rx App | February 6, 2026 |
| K252164 | imricor medical systems | NorthStar Mapping System | January 28, 2026 |
| K254085 | biosense webster | CARTO 3 EP Navigation System V9.0 with PIU Plus | January 18, 2026 |
| K253733 | rhythm ai | STAR Apollo Mapping System | December 19, 2025 |
| K252533 | edwards lifesciences | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) | December 18, 2025 |
| K253141 | medicalgorithmics | DeepRhythmAI | December 11, 2025 |
| K252429 | vektor medical | Vektor Computational ECG Mapping System (vMap®) | December 4, 2025 |
| K252238 | coroventis research | CoroFlow Cardiovascular System | October 24, 2025 |
| K252645 | philips medical systems nederland | LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub | October 24, 2025 |
| K253034 | edwards lifesciences | HemoSphere Stream Module | October 21, 2025 |
| K252013 | abbott medical | EnSite X EP System | September 25, 2025 |
| K251518 | volta medical | Volta AF-Xplorer II | September 12, 2025 |
| K251463 | abbott medical | EnSite X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite X | September 4, 2025 |
| K252302 | biosense webster | CARTO 3 EP Navigation System V8.1 | August 22, 2025 |
| K251234 | abbott medical | EnSite X EP System | July 30, 2025 |
| K243781 | edwards lifesciences | HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); Hem | July 23, 2025 |