Device type
Computer, Diagnostic, Programmable
Product code DQK · Class II · 21 CFR 870.1425 · Cardiovascular
Recent 510(k)s
Oct 30, 2026
K261886
VIVO (9002)
Catheter Precision, Inc.
- DQK
- Class II
Oct 27, 2026
K254226
PulseAPI SmartWatch
PulseAI, Ltd.
- DQK
- Class II
Oct 23, 2026
K263380
STAR Apollo™ Mapping System
Rhythm AI, Ltd.
- DQK
- Class II
Oct 1, 2026
K263016
Intra-Operative Positioning System (IOPS) and IOPS Visionary System
Centerline Biomedical
- DQK
- Class II
Sep 25, 2026
K254255
S-Patch CardioAI
Wellysis Corp.
- DQK
- Class II
Sep 17, 2026
K261729
EnSite™ X EP System
Abbott Medical
- DQK
- Class II
Aug 21, 2026
K253692
AVVIGO™+ Multi-Modality Guidance System
Boston Scientific
- DQK
- Class II
Aug 21, 2026
K262005
Affera Integrated Mapping System
Medtronic, Inc.
- DQK
- Class II
Recent recalls
Sep 23, 2026
Z-3143-2026
Carescape Central Station CSCS V3 MAS800 Desktop Part Number 5867474-04, 5867474-13 Product code STU CSCS V3 MAI800 Integrated Part Number 5867474-03 Product C…
GE Medical Systems Information Technologies Inc
- DQK
- Class II
- Ongoing