Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

56 results for "Volcano Corporation"
1–24 of 56
Search insights Median review: 62d Cleared: 100% Top manufacturer: Volcano Corporation Lead specialty: Radiology
Cleared Oct 28, 2025
Visions® PV .014P RX Digital IVUS Catheter
K253399 · OBJ
Volcano Corporation (Dba Philips...
Cardiovascular · 28d
Cleared Apr 15, 2021
Verrata PLUS Pressure Guide Wire
K210235 · DQX
Volcano Corporation
Cardiovascular · 77d
Cleared Jan 19, 2021
IntraSight Mobile
K203719 · IYO
Volcano Corporation
Cardiovascular · 29d
Cleared Sep 28, 2020
OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide...
K202543 · DQX
Volcano Corporation
Cardiovascular · 26d
Cleared Mar 26, 2020
OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide...
K192886 · DQX
Volcano Corporation
Cardiovascular · 168d
Cleared Apr 12, 2019
SyncVision System
K190626 · OWB
Volcano Corporation
Radiology · 32d
Cleared Feb 11, 2019
IntraSight
K190078 · DSA
Volcano Corporation
Cardiovascular · 26d
Cleared Apr 11, 2018
s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i Intravascular...
K173860 · IYO
Volcano Corporation
Radiology · 112d
Cleared Oct 25, 2017
CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software...
K172455 · IYO
Volcano Corporation
Radiology · 72d
Cleared Oct 05, 2017
SyncVision System
K172574 · OWB
Volcano Corporation
Radiology · 38d
Cleared Apr 06, 2017
CORE M2 Vascular System
K170385 · IYO
Volcano Corporation
Radiology · 57d
Cleared Oct 26, 2016
REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip
K160583 · OBJ
Volcano Corporation
Cardiovascular · 239d
Cleared Sep 20, 2016
Verrata PLUS Pressure Guide Wire, 185 cm Straight Tip, Verrata PLUS Pressure...
K161887 · DQX
Volcano Corporation
Cardiovascular · 71d
Cleared Sep 05, 2016
SyncVision System
K161756 · OWB
Volcano Corporation
Radiology · 70d
Cleared Dec 31, 2015
Visions PV .035 Digital IVUS Catheter
K153094 · OBJ
Volcano Corporation
Cardiovascular · 66d
Cleared Dec 22, 2015
SW v3.5 Install Kit, CORE Mobile, SW v3.5 Install Kit, CORE, SW v3.5 Install...
K153369 · IYO
Volcano Corporation
Radiology · 29d
Cleared Dec 03, 2015
CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box
K152582 · DSK
Volcano Corporation
Cardiovascular · 84d
Cleared Nov 19, 2015
Visions PV.014P RX Digital IVUS Catheter
K152829 · OBJ
Volcano Corporation
Cardiovascular · 51d
Cleared Sep 04, 2015
Volcano Visions PV .018 Digital IVUS Catheter
K150442 · OBJ
Volcano Corporation
Cardiovascular · 196d
Cleared Aug 26, 2015
EAGLE EYE PLATINUM CATHETER, EAGLE EYE PLATINUM SHORT TIP CATHETER, VISIONS...
K143701 · OBJ
Volcano Corporation
Cardiovascular · 245d
Cleared Jul 31, 2015
SyncVision System
K151904 · OWB
Volcano Corporation
Radiology · 18d
Cleared Apr 03, 2015
Crux Vena Cava Filter System, femoral
K150262 · DTK
Volcano Corporation
Cardiovascular · 58d
Cleared Mar 20, 2015
Volcano iFR Modality, iFR Scout feature
K150441 · IYO
Volcano Corporation
Radiology · 28d
Cleared CT Feb 20, 2015
Volcano iFR Harvest Software (Offline)
K143122 · IYO
Volcano Corporation
Radiology · 112d