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Volcano Corporation

22 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Philips Volcano FFR software used in the following systems connected to the McKesson, Schw recall (Z-0674-2020)Volcano Corporation2019-12-12
Philips Volcano CORE M2 Vascular System, Part # 400-0100.17, Rx Only. Used for the qualita recall (Z-1891-2018)Volcano Corporation2018-05-17
Refinity Rotational Intravascular Ultrasound (IVUS) Catheter; Product number: 400-0200.289 recall (Z-1775-2017)Volcano Corporation2017-04-10
Refinity Short Tip Rotational Intravascular Ultrasound (IVUS) Catheter; Product number: 40 recall (Z-1776-2017)Volcano Corporation2017-04-10
Volcano R100 Sterile Equipment Cover; Sterile; General Hospital: These Sterile Equipment c recall (Z-1041-2016)Volcano Corporation2016-03-03
Volcano SpinVision Sterile Equip cover II; Sterile; General Hospital: These Sterile Equipm recall (Z-1042-2016)Volcano Corporation2016-03-03
Volcano Pioneer Plus Re-Entry Catheter; Product Code PPLUS20, Catheter for Crossing Total recall (Z-2718-2015)Volcano Corporation2015-09-02
Volcano s5/s5i/CORE Intravascular Ultrasound Systems with software versions 3.3 and 3.4 (w recall (Z-2131-2015)Volcano Corporation2015-07-20
Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with a recall (Z-2132-2015)Volcano Corporation2015-07-20
Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with a recall (Z-2133-2015)Volcano Corporation2015-07-20
Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with a recall (Z-2134-2015)Volcano Corporation2015-07-20
Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with a recall (Z-2135-2015)Volcano Corporation2015-07-20
Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with a recall (Z-2136-2015)Volcano Corporation2015-07-20
Volcano PV .035 Catheter: Part number: 88901; Product Usage: The Volcano PV .035 is indica recall (Z-1844-2015)Volcano Corporation2015-06-25
Prestige Plus 185cm J-Tip: Part number: 9185J; Product Usage: The Prestige Plus Wire is in recall (Z-1845-2015)Volcano Corporation2015-06-25
Volcano TrakBack II Disposable Pullback Device; Sterile and nonpyrogenic; Single Use. Trak recall (Z-2636-2014)Volcano Corporation2014-09-12
Volcano brand Intravascular Ultrasound, Volcano s5/s5i Family Software Version 3.2.1 or 3. recall (Z-2345-2012)Volcano Corporation2012-09-10
Volcano pcFM Software Kit ; Manufactured by: Volcano Corporation, 2870 Kilgore Road, Ranch recall (Z-0973-2012)Volcano Corporation2012-02-07
FloWire Doppler Guide wires. Volcano Corporation, Rancho Cardova, Ca. The Volcano FloWire recall (Z-0935-2012)Volcano Corporation2012-02-01
Lumen Biomedical Xtract Aspiration Catheter system, intravascular catheter, consisting of recall (Z-0445-2011)Volcano Corporation2010-11-23
Volcano s5/s5i imaging system Family Software version 3.2, Part Numbers 435-0602.01 to 05, recall (Z-0168-2011)Volcano Corporation2010-11-01
Volcano s5 Imaging system, Ultrasound pulsed echo imaging system. Product consists of the recall (Z-1190-2007)Volcano Corporation2007-08-23

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Every clearance here is in the API, with alerts when new ones post.