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FDA 510(k) Applications Submitted by Marcus Garcia
FDA 510(k) Number
Submission Date
Device Name
Applicant
K140291
02/05/2014
VOLCANO CORE CONTROL PAD, ACCESSORY TO THE VOLCANO S5/S5I INTRAVASCULAR ULTRASOUND IMAGING & PRESSURE SYSTEMS
VOLCANO CORPORATION
K181465
06/04/2018
SpaceOAR System
Augmenix, Inc.
K132659
08/26/2013
VOLCANO PREVIEW FORWARD-LOOKING IVUS SYSTEM
VOLCANO CORPORATION
K182971
10/26/2018
SpaceOAR Vue Hydrogel
Augmenix, Inc
K133641
11/27/2013
CORE CONTROL PAD, CORE SERIES SW V3.4 INSTALLATION KIT, CORE, CORE MOBILE
VOLCANO CORPORATION
K143701
12/24/2014
EAGLE EYE PLATINUM CATHETER, EAGLE EYE PLATINUM SHORT TIP CATHETER, VISIONS PV .014 PLATINUM
VOLCANO CORPORATION
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