Spectrawave, Inc. - FDA 510(k) Cleared Devices
6
Total
6
Cleared
0
Denied
FDA 510(k) cleared devices by Spectrawave, Inc. Cardiovascular ✕
5 devices
Cleared
Dec 15, 2025
HyperVue™ Imaging System - Integrated
Cardiovascular
82d
Cleared
Jul 16, 2025
HyperVue™ Software
Cardiovascular
90d
Cleared
Mar 20, 2025
Starlight Imaging Catheter
Cardiovascular
174d
Cleared
Jun 07, 2023
HyperVue™ Imaging System
Cardiovascular
86d
Cleared
Feb 28, 2023
SpectraWAVE Imaging System
Cardiovascular
302d