Synaptic Medical Corporation - FDA 510(k) Cleared Devices
Recent clearances: Nordica PV Cryo Mapping Catheter, Accusafe Transseptal Guidewire (GTR31180, GTR31230), NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01)
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Synaptic Medical Corporation Cardiovascular ✕
4 devices
Cleared
Sep 06, 2024
Nordica PV Cryo Mapping Catheter
Cardiovascular
270d
Cleared
Jul 26, 2024
Accusafe Transseptal Guidewire (GTR31180, GTR31230)
Cardiovascular
178d
Cleared
Feb 16, 2024
NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01)
Cardiovascular
88d
Cleared
Feb 14, 2022
RithmID-SD Steerable Diagnostic Electrophysiology Catheter
Cardiovascular
413d