ClearanceBrief
Panels › Cardiovascular › Product code KRA · Class 2

Catheter, Continuous Flush

Regulation 870.1210

5510(k)s in 12 months (177 all time)
41recalls in 12 months (137 all time)
135recalls that name a 510(k)
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Top companies in KRA

Decided510(k)Device and applicantCode
Jan 6, 2016K153502ClariVein IC
Vascular Insights, LLC
KRA
Sep 10, 2014K142259Direxion Torqueable Microcatheter
Boston Scientific Corp
KRA
May 15, 2014K140329RENEGADE HI-FLO MICROCATHETER, MICROCATHETER KIT, FATHOM SYSTEM, FATHOM KIT
Boston Scientific
KRA
Mar 26, 2014K140637PEREGRINE SYSTEM INFUSION CATHETER
Ablative Solutions, Inc.
KRA
Feb 20, 2014K131772CANTATA(R) 2.9 MICROCATHETER
Cook, Inc.
KRA
Nov 15, 2013K130569ND NABIL DIB INFUSION CATHETER
Translational Research Institute
KRA
Oct 18, 2013K132947DIREXION AND DIREXION HI-FLO TORQUEABLE MICROCATHETERS
Boston Scientific Corp
KRA
Mar 19, 2013K123477VIA MICROCATHETER, VIA PLUS MICROCATHETER
Sequent Medical, Inc.
KRA
Oct 11, 2012K122796CXI SUPPORT CATHETER
Cook, Inc.
KRA
Aug 1, 2012K113289ORION MICRO CATHETER
Micro Therapeutics, Inc.
KRA
Jan 18, 2012K113773ST JUDE MEDICAL, IS4 FLUSHING/FUNNELING TOOL
St Jude Medical
KRA
Sep 16, 2011K111490MARKSMAN CATHETER, *REFERS TO DIFFERENT CATHETER WORKING LENGHTS, DISTAL SINGLE COILED LENGTHS AND DISTAL SHAFT LENGTHS
Ev3, Inc.
KRA
Jul 25, 2011K111263CXI TRIFORCE
Cook Incorporated
KRA
Dec 30, 2010K101450CANTATA MICROCATHETER
Cook, Inc.
KRA
Apr 12, 2010K100892RENEGADE HI-FLO FATHOM KIT MODEL M001182XXX
Boston Scientific Corp
KRA
Dec 9, 2009K093750ECHELON MICRO CATHETER, MARATHON MICRO CATHETER, NAUTICA MICRO CATHETER ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER, REBA
Ev3, Inc.
KRA
Dec 8, 2009K093052CROSSCATH SUPPORT CATHTER
Cook, Inc.
KRA
Sep 18, 2009K091559MARKSMANN CATHETER
Chestnut Medical Technologies, Inc.
KRA
May 29, 2009K081147ISOFLOW INFUSION CATHETER
Vascular Designs, Inc.
KRA
May 1, 2009K090870ECHELON MICRO CATHETER, MODELS 105-5092-150SA, 145-5092-150SA AND 190-5092-150SA AND SYRINGE ADAPTER ACCESSORY
Micro Therapeutics, Inc.
KRA
Dec 30, 2008K082613MERIT MICROCATHETER
Merit Medical Systems, Inc.
KRA
Oct 29, 2008K082163FLOWMEDICA BENEPHIT INFUSION SYSTEMS
Flowmedica, Inc.
KRA
Sep 26, 2008K082519FINECROSS MG CORONARY MICRO-GUIDE CATHETER
Terumo Medical Corp.
KRA
Aug 8, 2008K080737MIRAFLEX HIGH FLOW MICROCATHETER
Cook, Inc.
KRA
Jul 3, 2008K053310VASCON ROAMER MICROCATHETER
Vascon, LLC
KRA
Apr 22, 2008K073166ENDOWAVE INFUSION SYSTEM
Ekos Corp.
KRA
Mar 20, 2008K071468CLARIVEIN CATHETER
Vascular Insights, LLC
KRA
Dec 20, 2007K073400VARICATH PERIPHERAL INFUSION CATHETER
Veinrx, Inc.
KRA
Nov 9, 2007K072724CXI SUPPORT CATHETER
Cook, Inc.
KRA
Sep 19, 2007K070979PULL TAB SQUEEZE FLUSH
Icu Medical, Inc.
KRA
Mar 29, 2007K070384ARGON CONTINUOUS FLUSH DEVICE
Argon Medical Devices, Inc.
KRA
Mar 14, 2007K070279MODIFICATION TO HYPERTRANSIT INFUSION CATHETER
Cordis Neurovascular, Inc.
KRA
Dec 7, 2006K062752MERCATOR MICROSYRINGE II INFUSION CATHETER
Mercator Medsystems, Inc.
KRA
Mar 6, 2006K060224MODIFICATION TO MIRA-FLEX 18 MICROCATHETER
Cook Incorporated
KRA
Jan 4, 2006K051990ECHELON MICRO CATHETER
Micro Therapeutics, Inc.
KRA
Dec 8, 2005K052841MIRA-FLEX 18 MICROCATHETER
Cook, Inc.
KRA
Dec 6, 2005K052738INFUSIONCATH PERIPHERAL INFUSION CATHETER, MODELS VF0012, VF0016, VF0024, VF0028, VF0032, VF0036, VF0040, VF0044
Veinrx, Inc.
KRA
Apr 18, 2005K043538HYPERTRANSIT INFUSION CATHETER
Cordis Neurovascular, Inc.
KRA
Mar 22, 2005K050630PIVOT STEERABLE MICROCATHETER
Boston Scientific - Precision Vascular
KRA
Mar 4, 2005K050205BENEPHIT BIFURCATED INFUSION CATHETER AND 5FR. INTRODUCER SHEATH
Flowmedica, Inc.
KRA
Sep 2, 2004K042187ECHELON 10,45 TIP SHAPE MICRO CATHETER ECHELON 10,90 TIP SHAPE MICRO CATHETER, ECHELON 14,45 TIP SHAPE MICRO CATHETER,90
Micro Therapeutics, Inc.
KRA
Mar 11, 2004K033913PROGREAT
Terumo Medical Corp.
KRA
Feb 18, 2004K040139ENDOBIONICS MICROSYRINGE (USYRINGE) INFUSION CATHETER
Endobionics, Inc.
KRA
Feb 13, 2004K034036MARATHON FLOW DIRECTED MICRO CATHETER, MODEL 105-5055
Micro Therapeutics, Inc.
KRA
Jan 16, 2004K033726PVS PIVOT STEERABLE DELIVERY SYSTEM MICROCATHETER
Precision Vascular
KRA
Jan 13, 2004K033569FLOWMEDICA BIFURCATED INFUSION SYSTEM, INFUSION CATHETER AND INTRODUCER SHEATH
Flowmedica, Inc.
KRA
Sep 5, 2003K032494PVS 1700 STEERABLE DELIVERY SYSTEM MICROCATHETER
Precision Vascular Systems, Inc.
KRA
Aug 7, 2003K031992ECHELON MICRO CATHETER, MODEL 105-5091
Micro Therapeutics, Inc.
KRA
Mar 28, 2003K030688ECHELON MICRO CATHETER, MODEL 105-5092-150
Micro Therapeutics, Inc.
KRA
Mar 7, 2003K024122NAUTICA MICRO CATHETER, MODEL 105-5094-153
Micro Therapeutics, Inc.
KRA

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