ClearanceBrief
Panels › Cardiovascular › Product code MCW · Class 2

Catheter, Peripheral, Atherectomy

Regulation 870.4875

1510(k)s in 12 months (146 all time)
0recalls in 12 months (34 all time)
33recalls that name a 510(k)
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Top companies in MCW

Company510(k)sRecalls
Cardiovascular Systems Incorporated2112
Pathway Medical Technologies, Inc.160
Spectranetics105
Ev3 Corporation47
Avinger, Inc.100
Eximo Medical80
Rex Medical80
Boston Scientific Corp51
Volcano Atheromed, Inc.60
Cardio Flow Inc.,40
Decided510(k)Device and applicantCode
Oct 14, 2015K152275Pantheris System
Avinger, Inc.
MCW
Jun 10, 2015K151260ViperWire Advance Guide Wire, Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Orbital PAD
Cardiovascular System, Inc.
MCW
May 26, 2015K1511452.4mm X 127 cm Phoenix Atherectomy Deflecting System
Volcano Atheromed, Inc.
MCW
Apr 13, 2015K150732Diamondback 360 Peripheral Orbital Atherectomy System
Cardiovascular Systems, Inc.
MCW
Dec 19, 2014K1433281.8mm X 149 cm Phoenix Atherectomy Catheter, 2.2mm X 149 cm Phoenix Atherectomy Catheter, Phoenix Handle, Phoenix Wire S
Volcano Atheromed, Inc.
MCW
Oct 16, 2014K141801HAWKONE DIRECTIONAL ATHERECTOMY SYSTEM
Covidien, LLC
MCW
Aug 27, 2014K133023JETSTREAM XC 2.4/3.4; JETSTREAM XC 2.1/3.0; JETSTREAM SC 1.85; JETSTREAM SC 1.6
Medrad, Inc.
MCW
Aug 22, 2014K1409441.8 MM PHOENIX ATHERECTOMY CATHETER, 2.2 MM PHOENIX ATHERECTOMY CATHETER, PHOENIX HANDLE, PHOENIX WIRE SUPPORT CLIP
Atheromed, Inc.
MCW
Jul 23, 2014K140775TURBO-ELITE ATHERECTOMY CATHETERS, TURBO TANDEM SYSTEM
Spectranetics Corporation
MCW
Feb 28, 2014K133999DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
Cardiovascular Systems, Inc.
MCW
Jan 17, 2014K132682PHOENIX 5F TRACKING ATHERECTOMY CATHETER, PHOENIX 6F TRACKING ATHERECTOMY CATHETER, PHOENIX 7D DEFLECTING ATHERECTOMY CA
Atheromed, Inc.
MCW
Dec 20, 2013K133566ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH THE PERIPHERAL ROTALINK PLUS
Boston Scientific Corp
MCW
Nov 22, 2013K133399DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
Cardiovascular Systems Incorporated
MCW
Jun 24, 2013K131092STEALTH 360 ORBITAL PAD SYSTEM
Cardio Systems, Inc.
MCW
Apr 10, 2013K130637JETSTREAM XC 2.4/3.4 SYSTEM; JETSTREAM XC 2.1/3.0 SYSTEM; JETSTREAM SC 1.85 SYSTEM; JETSTREAM SC 1.6 SYSTEM
Medrad, Inc.
MCW
Jan 25, 2013K1236322.5MM TURBO ELITE 035, 2.3MM TURBO ELITE 035
Spectranetics Corp.
MCW
Oct 25, 2012K122987STEALTH 360 ORBITAL PAD SYSTEM
Cardiovascular Systems, Inc.
MCW
Oct 19, 2012K122916JETSTREAM NAVITUS L SYSTEM JEYSTREAM NAVITUS SYSTEM JETSTREAM G3 SF SYSTEM JETSTREAM SF 1.6 SYSTEM
Medrad, Inc.
MCW
Sep 13, 2012K121774ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH PERIPHERAL ROTALINK PLUS
Boston Scientific Corp
MCW
Jun 1, 2012K120346CLEANER ROTATIONAL THROMBECTOMY SYSTEM
Rex Medical
MCW
Feb 24, 2012K120242JETSTREAM NAVITUS L SYSTEM
Pathway Medical Technologies, Inc.
MCW
Oct 27, 2011K111723TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM
Ev3, Inc.
MCW
Jul 26, 2011K111388DIAMONDBACK 360* ORBITAL ATHERECTOMY SYSTEM, STEALTH 360* ORBITAL PAD SYSTEM
Cardiovascular Systems, Inc.
MCW
Jun 1, 2011K111229JETSTREAM G3 (R) SF 1.6 SYSTEM
Pathway Medical Technologies, Inc.
MCW
Apr 20, 2011K110626JETSTREAM NAVITUS SYSTEM; JETSTREAM G3 SF SYSTEM; JETSTREAM G3 SE SYSTEM; JETSTREAM G3 L SYSTEM
Pathway Medical Technologies, Inc.
MCW
Mar 11, 2011K110389STEALTH 360 ORBITAL PAD SYSTEM
Cardiovascular Systems, Inc.
MCW
Jan 5, 2011K103618TURBOHAWK PEROPHERAL PLAQUE EXCISION SYSTEM
Ev3, Inc.
MCW
Jun 11, 2010K101334JETSTREAM G3 SE SYSTEM, JETSTREAM G3 SF SYSTEM MODEL PV31230 (JETSTREAM G3 SE CATHETER AND CONTROL POD); PVCN100 (PV CON
Pathway Medical Technologies, Inc.
MCW
Jun 2, 2010K101221JETSTREAM G3 SYSTEM, MODEL PV31300, PV CONSOLE, MODEL PVCN100
Pathway Medical Technologies, Inc.
MCW
May 19, 2010K100462JETSTREAM G3 L SYSTEM, PV CONSOLE, MODELS PV31400, PV31300, PVCN100
Pathway Medical Technologies, Inc.
MCW
Feb 18, 2010K091029CLEANER ROTATIONAL THROMBECTOMY SYSTEM (9 MM X 65 CM) AND (9 MM X 120 CM)
Rex Medical
MCW
Jan 25, 2010K094036TURBO-TANDEM SYSTEM MODEL 472-110
Spectranetics Corp.
MCW
Jan 21, 2010K093918JETSTREAM G3 L SYSTEM MODEL PV31400 (JETSTREAM G3 L CATHETER WITH CONTROL POD); PVCN100 (PV CONSOLE)
Pathway Medical Technologies, Inc.
MCW
Dec 1, 2009K093456JETSTREAM G3 SYSTEM
Pathway Medical Technologies, Inc.
MCW
Nov 6, 2009K093301TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM
Ev3, Inc.
MCW
Sep 3, 2009K092332JETSTREAM G3 SYSTEM, MODEL PV31300 ( JETSTREAM G3 CATHETER AND CONTROL POD)., PVCN100 (PV CONSOLE)
Pathway Medical Technologies, Inc.
MCW
Jun 19, 2009K091509JETSTREAM G2 NXT SYSTEM, MODEL PV20300
Pathway Medical Technologies, Inc.
MCW
Mar 20, 2009K090521DIAMONDBACK 360 DBX
Cardiovascular Systems, Inc.
MCW
Mar 11, 2009K090325JETSTREAM G2 SYSTEM, MODELS PV20300 (JETSTREAM G2 CATHETER AND CONTROL POD); PVCN100 (PV CONSOLE)
Pathway Medical Technologies, Inc.
MCW
Jan 23, 2009K083489JETSTREAM PATHWAY PC ATHERECTOMY SYSTEM, MODEL OV10300
Pathway Medical Technologies, Inc.
MCW
Jan 13, 2009K083837JETSTREAM G2 SYSTEM, MODELS PV20300 (JETSTREAM G2 CATHETER AND CONTROL POD); PVCN100 (PV CONSOLE)
Pathway Medical Technologies, Inc.
MCW
Oct 31, 2008K082981DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM WITH VIPERSLIDE LUBRICANT
Cardiovascular Systems, Inc.
MCW
Oct 6, 2008K082664JETSTREAM PATHWAY PV ATHERECTOMY SYSTEM, MODEL PV10300, PVCN100
Pathway Medical Technologies, Inc.
MCW
Aug 29, 2008K082186MODIFICATION TO PATHWAY PV ATHERECTOMY SYSTEM
Pathway Medical Technologies, Inc.
MCW
Aug 14, 2008K081944MODIFICATION TO DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM
Cardio Systems, Inc.
MCW
Jul 17, 2008K081328PATHWAY PV ATHERECTOMY SYSTEM
Pathway Medical Technologies, Inc.
MCW
Feb 12, 2008K071432SILVERHAWK-R PERIPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE
Fox Hollow Technologies
MCW
Nov 9, 2007K072748MODIFICATION TO: DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM
Cardiovascular Systems, Inc.
MCW
Oct 25, 2007K072800DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM
Cardiovascular Systems, Inc.
MCW
Aug 30, 2007K071427DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS
Cardiovascular Systems, Inc.
MCW

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