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

DateFirm and productCodeLinked 510(k)
Nov 9, 2017Vascular Insights, LLC
ClariVein IC infusion catheter, Model Number: 65-018-E4S Product Usage: The ClariVein IC infusion catheter is indicated for infusion of physician-specified agents into the peripheral vasculature.
Terminated
KRAK071468
Feb 1, 2017Cook Inc.
TriForce Peripheral Crossing Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. The TriForce Peripheral Crossing Set is intended to be percutaneously introduced into blood v
Terminated
KRAK132592
Nov 9, 2016Micro Therapeutics Inc, Dba Ev3 Neurovascular
Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion o
Terminated
KRANone listed
Oct 27, 2016Sequent Medical Inc
VIA 27 Microcatheter, Part No. FG27-154-01, Model No. VIA-27-154-01 The VIA 27 is intended for the introduction of non-liquid interventional devices (such as stents/flow diverters) and infusion of d
Terminated
KRAK132652
Aug 9, 2016EKOS Corporation
EkoSonic Endovascular Devices EKOS Intelligent Drug Delivery Catheter
Terminated
KRAK081467
K111705 +1
Feb 24, 2016EKOS Corporation
EkoSonic Endovascular System, Catalog Number 500-56112. It consists of three main components, a single use EkoSonic Endovascular Device which is comprised of an Intelligent Drug Delivery Catheter (ID
Terminated
KRAK081467
K111705 +1
Nov 6, 2015Cook Inc.
Cook Medical CXI Support Catheter 2.6FR curved catheter and 4.0FR straight catheter, for cardiovascular use.
Terminated
KRAK072724
Jul 20, 2015EKOS Corporation
The EKOS EkoSonic Control Unit is intended exclusively for use with the EkoSonic Endovascular Device and the EkoSonic MACH4 Endovascular Device. The EkoSonic Endovascular System consists of three mai
Terminated
KRAK081467
K111705 +1
Apr 2, 2015Medtronic Inc. Cardiac Rhythm Disease Management
Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx only. Models BVT608010V01, BVT608030V01, BVT612010V01, BVT612030V01, CVT808015, CVT808025, CVT812015, CVT812025, EVT808015,
Terminated
KRAK071664
K130904
Feb 3, 2015Covidien
Covidien Trellis-8 Peripheral Infusion System. Models CVT808015, CVT808025, CVT812015, and CVT812025. The following models are not offered for sale in the US: EVT808015, EVT808025, EVT812015, and E
Terminated
KRAK130904
Feb 3, 2015Covidien
Covidien Trellis-6 Peripheral Infusion System. Models BVT608010V01, BVT608030V01, BVT612010V01, and BVT612030V01. Sterile EO. Product Usage: Intended for controlled and selective infusion of physic
Terminated
KRAK071664
Oct 31, 2014Merit Medical Systems, Inc.
Merit Maestro Microcatheter, 2.4F 130cm Straight, REF28MC24130ST, Rx Only, Non-pyrogenic Sterile if package is unopened or undamaged.
Terminated
KRAK082613
Aug 18, 2014Angiodynamics, Inc.
Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 40 cm Infusion Pattern, Catalog No./REF 12401809, Product No. H787124018095, STERILE -- AngioDynamics, 603 Queensbury Avenue, Queensbury, NY 128
Terminated
KRAK905447
K951602 +1
Aug 18, 2014Angiodynamics, Inc.
Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 30 cm Infusion Pattern, Catalog No./REF 12401808, Product No. H787124018085, STERILE -- AngioDynamics, 603 Queensbury Avenue, Queensbury, NY 128
Terminated
KRAK905447
K951602 +1
Aug 18, 2014Angiodynamics, Inc.
Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 10 cm Infusion Pattern, Catalog No./REF 12401806, Product No. H787124018065, STERILE -- AngioDynamics, 603 Queensbury Avenue, Queensbury, NY 128
Terminated
KRAK905447
K951602 +1
Dec 31, 2013Merit Medical Systems, Inc.
Catheter, Continuous Flush The Merit Microcatheter is intended for general intravascular use, including peripheral and coronary vasculature. Once the subselective region has been accessed, the microca
Terminated
KRAK082613
Nov 1, 2013EKOS Corporation
The EkoSonic Endovascular System employs high frequency (2-2.5 MHz), low power (0.585 watt average power per transducer) ultrasound to facilitate the delivery of physician-specified fluids in the peri
Terminated
KRAK081467
K111705
Apr 18, 2013Edwards Lifesciences, LLC
Pressure Monitoring sets with VAMP Plus closed blood sampling system model # T001691A, PXVP0566, PXVP2260, PXVP0826, PXVP0827, PXVP2284AT3, PXVP23X3AT3, T398807D, T100605B, T001762A, T391T00A, VP2. B
Terminated
KRAK896819
K925638
Sep 27, 2012Micro Therapeutics Inc, Dba Ev3 Neurovascular
Marathon Flow Directed Micro Catheter, Model #105-5055. Product Usage: The Marathon Flow Directed Micro Catheter is intended to access the peripheral and neuro vasculature for the controlled selectiv
Terminated
KRAK034036
Sep 27, 2012Micro Therapeutics Inc, Dba Ev3 Neurovascular
UltraFlow HPC Flow Directed Micro Catheter, Model # 105-5065. Product Usage: The UltraFlow HPC Flow Directed Micro Catheter is intended to access peripheral and neuro vasculature for the controlled s
Terminated
KRAK024118
Jul 17, 2012EKOS Corporation
EkoSonic MACH4 Endovascular Device (Catalog #500-55106, 500-55112; 500-55118; 500-55124; 500-55130; 500-55140; 500-55150; 500-54106; 500-56130; 500-56140; 500-56150) is a catheter, continuous infusio
Terminated
KRAK081467
K111705
Feb 28, 2012Angiodynamics Worldwide Headquarters
AngioDynamics BENEPHIT CV Infusion System Targeted Renal Therapy Infusion System --- Catalog No. [REF] 60040 --- Manufactured in USA --- [Mfg symbol] AngioDyanamics, 603 Queensbury Avenue, Queensbury,
Terminated
KRAK082163
Feb 28, 2012Angiodynamics Worldwide Headquarters
AngioDynamics BENEPHIT CV Infusion System Targeted Renal Therapy Infusion System --- Catalog No. [REF] 60030 --- Manufactured in USA --- [Mfg symbol] AngioDyanamics, 603 Queensbury Avenue, Queensbury,
Terminated
KRAK082163
Feb 28, 2012Angiodynamics Worldwide Headquarters
AngioDynamics BENEPHIT CV Infusion System Targeted Renal Therapy Infusion System --- Catalog No. [REF] 60035 --- Manufactured in USA --- [Mfg symbol] AngioDyanamics, 603 Queensbury Avenue, Queensbury,
Terminated
KRAK082163
Jan 11, 2012Angiodynamics Worldwide Headquarters
Benephit XT Infusion System, Targeted Renal Therapy Infusion System, Catalog/REF 70035, STERILE -- AngioDynamics Inc. 603 Queensbury, NY 12804 USA --- COMMON/USUAL NAME - Continuous flush catheter;
Terminated
KRAK082163
Sep 19, 2011Angiodynamics Worldwide Headquarters
ANGIODYNAMICS UNI*FUSE INFUSION SYSTEM WITH COOPER WIRE, Catalog No./REF 12401819, CATHETER SIZE 4F, CATHETER LENGTH 90 cm, INFUSION LENGTH 20 cm, OCCLUSION WIRE SIZE .035 in., STERILE, AngioDynamics
Terminated
KRAK951509
Sep 19, 2011Angiodynamics Worldwide Headquarters
ANGIODYNAMICS UNI*FUSE INFUSION SYSTEM WITH COOPER WIRE, Catalog No./REF 12401818, CATHETER SIZE 4F, CATHETER LENGTH 90 cm, INFUSION LENGTH 10 cm, OCCLUSION WIRE SIZE .035 in., STERILE, AngioDynamics
Terminated
KRAK951509
Nov 15, 2010Boston Scientific Corporation
Boston Scientific brand Renegade Fiber Braided Microcatheter, 150/10/2RO, Rx Only; Model Numbers: 18257, 18259; Product is distributed by Boston Scientific Corporation, Natick, MA; Product is manufa
Terminated
KRAK973645
Nov 15, 2010Boston Scientific Corporation
Boston Scientific brand Neuro Renegade Hi-Flo Microcatheter, 150cm/20cm; Rx Only; Model Numbers: 182880US, 182890US, 182900US, 182910US; Product is distributed by Boston Scientific Corporation, Natic
Terminated
KRAK000177
May 28, 2010Angiodynamics, Inc.
ANGIODYNAMICS BENEPHIT(TM) CV Infusion System, 35 cm, Targeted Renal Therapy Infusion system, Catalog/Model/REF Number 60035, STERILE, EO, Intended for Single Use Only. AngioDynamics, Incorporated 6
Terminated
KRAK033569
K050205 +1
May 28, 2010Angiodynamics, Inc.
ANGIODYNAMICS BENEPHIT(TM) XT Infusion System, 35 cm, Targeted Renal Therapy Infusion system, Model/REF Number 70035, STERILE, EO, Intended for Single Use Only. AngioDynamics, Incorporated 603 Queens
Terminated
KRAK033569
K050205 +1
May 27, 2010Angiodynamics, Inc.
PULSESPRAY INFUSION SYSTEM, 90 cm x 20 cm infusion length, Catalog No./Ref 12500402, STERILE, EO. AngioDynamics, 603 Queensbury Avenue, Queensbury, NY 12804. Infusion Catheter.
Terminated
KRAK905447
Mar 2, 2010Merit Medical Systems, Inc.
Mistique Infusion Catheter, K12-MIC04505, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Intended to administer infusions of various therapeutic solutions into the peripheral vascu
Terminated
KRAK974067
Mar 2, 2010Merit Medical Systems, Inc.
Mistique Infusion Catheter, K12-MIC04510, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Intended to administer infusions of various therapeutic solutions into the peripheral vascu
Terminated
KRAK974067
Mar 2, 2010Merit Medical Systems, Inc.
Mistique Infusion Catheter, K12-MIC09005, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Intended to administer infusions of various therapeutic solutions into the peripheral vascu
Terminated
KRAK974067
Mar 2, 2010Merit Medical Systems, Inc.
Mistique Infusion Catheter, K12-MIC09010, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Intended to administer infusions of various therapeutic solutions into the peripheral vascu
Terminated
KRAK974067
Mar 2, 2010Merit Medical Systems, Inc.
Mistique Infusion Catheter, K12-MIC13505, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Intended to administer infusions of various therapeutic solutions into the peripheral vascu
Terminated
KRAK974067
Mar 2, 2010Merit Medical Systems, Inc.
Mistique Infusion Catheter, K12-MIC13510, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Intended to administer infusions of various therapeutic solutions into the peripheral vascu
Terminated
KRAK974067
Mar 2, 2010Merit Medical Systems, Inc.
Mistique Infusion Catheter, MIC5-135-10-035, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Intended to administer infusions of various therapeutic solutions into the peripheral va
Terminated
KRAK974067
Mar 2, 2010Merit Medical Systems, Inc.
Mistique Infusion Catheter, MIC5-135-10-038, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Intended to administer infusions of various therapeutic solutions into the peripheral va
Terminated
KRAK974067
Mar 2, 2010Merit Medical Systems, Inc.
Mistique Infusion Catheter, MIC5-135-20-035, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Intended to administer infusions of various therapeutic solutions into the peripheral va
Terminated
KRAK974067
Mar 2, 2010Merit Medical Systems, Inc.
Mistique Infusion Catheter, MIC5-135-20-038, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Intended to administer infusions of various therapeutic solutions into the peripheral va
Terminated
KRAK974067
Mar 2, 2010Merit Medical Systems, Inc.
Mistique Infusion Catheter, MIC5-135-5-035, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Intended to administer infusions of various therapeutic solutions into the peripheral vas
Terminated
KRAK974067
Mar 2, 2010Merit Medical Systems, Inc.
Mistique Infusion Catheter, MIC5-135-5-038, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Intended to administer infusions of various therapeutic solutions into the peripheral vas
Terminated
KRAK974067
Mar 2, 2010Merit Medical Systems, Inc.
Mistique Infusion Catheter, MIC5-45-10-035, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Intended to administer infusions of various therapeutic solutions into the peripheral vas
Terminated
KRAK974067
Mar 2, 2010Merit Medical Systems, Inc.
Mistique Infusion Catheter, MIC5-45-10-038, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Intended to administer infusions of various therapeutic solutions into the peripheral vas
Terminated
KRAK974067
Mar 2, 2010Merit Medical Systems, Inc.
Mistique Infusion Catheter, MIC5-45-20-035, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Intended to administer infusions of various therapeutic solutions into the peripheral vas
Terminated
KRAK974067
Mar 2, 2010Merit Medical Systems, Inc.
Mistique Infusion Catheter, MIC5-45-20-038, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Intended to administer infusions of various therapeutic solutions into the peripheral vas
Terminated
KRAK974067
Mar 2, 2010Merit Medical Systems, Inc.
Mistique Infusion Catheter, MIC5-45-5-038, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Intended to administer infusions of various therapeutic solutions into the peripheral vasc
Terminated
KRAK974067
Mar 2, 2010Merit Medical Systems, Inc.
Mistique Infusion Catheter, MIC5-45-5-035, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Intended to administer infusions of various therapeutic solutions into the peripheral vasc
Terminated
KRAK974067

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