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"
25–48 of 56
Search insights Median review: 62d Cleared: 100% Top manufacturer: Volcano Corporation Lead specialty: Radiology
Cleared CT Mar 14, 2014
VOLCANO IFR MODALITY
K133323 · IYO
Volcano Corporation
Radiology · 136d
Cleared Mar 07, 2014
VOLCANO CORE CONTROL PAD, ACCESSORY TO THE VOLCANO S5/S5I INTRAVASCULAR...
K140291 · IYO
Volcano Corporation
Radiology · 30d
Cleared Jan 30, 2014
CRUX SNARE FILTER RETRIEVAL SET
K133681 · MMX
Volcano Corporation
Cardiovascular · 59d
Cleared Dec 20, 2013
CORE CONTROL PAD, CORE SERIES SW V3.4 INSTALLATION KIT, CORE, CORE MOBILE
K133641 · IYO
Volcano Corporation
Radiology · 23d
Cleared Dec 12, 2013
SYNC-RX SYSTEM
K132558 · OWB
Volcano Corporation
Radiology · 119d
Cleared Nov 15, 2013
VOLCANO LOMAP,VOLCANO LOMAP OPTION KIT FOR MOBILE SYSTEM,VOLCANO LOMAP OPTION...
K133142 · IYO
Volcano Corporation
Radiology · 29d
Cleared Sep 27, 2013
VOLCANO PREVIEW FORWARD-LOOKING IVUS SYSTEM
K132659 · DQY
Volcano Corporation
Cardiovascular · 32d
Cleared Jun 21, 2013
VERRATA PRESSURE GUIDE WIRE
K131288 · DQX
Volcano Corporation
Cardiovascular · 46d
Cleared Apr 29, 2013
REFLOW ASPIRATION CATHETER
K123482 · QEZ
Volcano Corporation
Cardiovascular · 167d
Cleared Apr 24, 2013
PREVIEW FORWARD-LOOKING IVUS CATHETER AND LAPTOP SYSTEM
K122826 · DQY
Volcano Corporation
Cardiovascular · 222d
Cleared Jan 14, 2013
VOLCANO S5/S5I INTRAVASCULAR ULTRASOUND IMAGING AND PRESSURE SYSTEM
K123898 · IYO
Volcano Corporation
Radiology · 27d
Cleared Sep 10, 2012
VISIONS PV .035 DITITAL IVUS CATHETER
K121273 · OBJ
Volcano Corporation
Cardiovascular · 136d
Cleared Apr 05, 2012
EAGLE EYE PLATINUM ST CATHETER
K120697 · OBJ
Volcano Corporation
Radiology · 29d
Cleared Jan 27, 2012
VOLCANO S5I INTRAVASCULAR ULTRACOUND IMAGING AND PRESSURE SYSTEM
K113486 · IYO
Volcano Corporation
Radiology · 65d
Cleared Jan 05, 2012
VALET MICRO CATHETER
K112035 · DQY
Volcano Corporation
Cardiovascular · 174d
Cleared Aug 01, 2011
PRIMEWIRE PRESTIGE PLUS
K111395 · DQX
Volcano Corporation
Cardiovascular · 74d
Cleared Jul 15, 2011
VOLCANO S5IINTRAVASCULAR IMAGING AND PRESSURE SYSTEM
K111706 · IYO
Volcano Corporation
Radiology · 28d
Cleared Apr 30, 2010
PRIMEWIRE PRESTIAGE PRESSURE GUIDE WIRE, MODELS 8185, 8185J, 8300, 8300J
K100930 · DQX
Volcano Corporation
Cardiovascular · 25d
Cleared Dec 10, 2009
EAGLE EYE PLATINUM DIGITAL IVUS CATHETER
K092596 · OBJ
Volcano Corporation
Radiology · 108d
Cleared Oct 08, 2008
S5/S5I SERIES INTRAVASCULAR IMAGING AND PRESSURE SYSTEM, COMBOMAP PRESSURE...
K082229 · IYO
Volcano Corporation
Radiology · 62d
Cleared May 12, 2008
REVOLUTION 45MHZ IVUS IMAGING CATHETER
K080891 · OBJ
Volcano Corporation
Cardiovascular · 42d
Cleared Jan 14, 2008
EAGLE EYE GOLD IVUS IMAGING CATHETER, MODEL 85900, AVABAR F/X IVUS IMAGING...
K073473 · OBJ
Volcano Corporation
Radiology · 34d
Cleared Jan 04, 2008
VOLCANO S5/S5I INTRAVASCULAR IMAGING AND PRESSURE SYSTEM
K071554 · OBJ
Volcano Corporation
Radiology · 211d
Cleared Aug 31, 2007
VISIONS PV 8.2 INTRAVASCULAR ULTRASOUND IMAGING CATHETER, MODEL 88900
K071660 · OBJ
Volcano Corporation
Cardiovascular · 74d