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)
Top companies in KRA
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 9, 2017 | Vascular 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 |
KRA | K071468 |
| Feb 1, 2017 | Cook 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 |
KRA | K132592 |
| Nov 9, 2016 | Micro 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 |
KRA | None listed |
| Oct 27, 2016 | Sequent 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 |
KRA | K132652 |
| Aug 9, 2016 | EKOS Corporation EkoSonic Endovascular Devices
EKOS Intelligent Drug Delivery Catheter Terminated |
KRA | K081467 K111705 +1 |
| Feb 24, 2016 | EKOS 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 |
KRA | K081467 K111705 +1 |
| Nov 6, 2015 | Cook Inc. Cook Medical CXI Support Catheter
2.6FR curved catheter and 4.0FR straight catheter, for cardiovascular use. Terminated |
KRA | K072724 |
| Jul 20, 2015 | EKOS 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 |
KRA | K081467 K111705 +1 |
| Apr 2, 2015 | Medtronic 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 |
KRA | K071664 K130904 |
| Feb 3, 2015 | Covidien 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 |
KRA | K130904 |
| Feb 3, 2015 | Covidien 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 |
KRA | K071664 |
| Oct 31, 2014 | Merit Medical Systems, Inc. Merit Maestro Microcatheter, 2.4F 130cm Straight, REF28MC24130ST, Rx Only, Non-pyrogenic Sterile if package is unopened or undamaged. Terminated |
KRA | K082613 |
| Aug 18, 2014 | Angiodynamics, 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 |
KRA | K905447 K951602 +1 |
| Aug 18, 2014 | Angiodynamics, 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 |
KRA | K905447 K951602 +1 |
| Aug 18, 2014 | Angiodynamics, 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 |
KRA | K905447 K951602 +1 |
| Dec 31, 2013 | Merit 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 |
KRA | K082613 |
| Nov 1, 2013 | EKOS 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 |
KRA | K081467 K111705 |
| Apr 18, 2013 | Edwards 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 |
KRA | K896819 K925638 |
| Sep 27, 2012 | Micro 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 |
KRA | K034036 |
| Sep 27, 2012 | Micro 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 |
KRA | K024118 |
| Jul 17, 2012 | EKOS 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 |
KRA | K081467 K111705 |
| Feb 28, 2012 | Angiodynamics 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 |
KRA | K082163 |
| Feb 28, 2012 | Angiodynamics 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 |
KRA | K082163 |
| Feb 28, 2012 | Angiodynamics 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 |
KRA | K082163 |
| Jan 11, 2012 | Angiodynamics 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 |
KRA | K082163 |
| Sep 19, 2011 | Angiodynamics 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 |
KRA | K951509 |
| Sep 19, 2011 | Angiodynamics 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 |
KRA | K951509 |
| Nov 15, 2010 | Boston 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 |
KRA | K973645 |
| Nov 15, 2010 | Boston 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 |
KRA | K000177 |
| May 28, 2010 | Angiodynamics, 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 |
KRA | K033569 K050205 +1 |
| May 28, 2010 | Angiodynamics, 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 |
KRA | K033569 K050205 +1 |
| May 27, 2010 | Angiodynamics, 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 |
KRA | K905447 |
| Mar 2, 2010 | Merit 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 |
KRA | K974067 |
| Mar 2, 2010 | Merit 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 |
KRA | K974067 |
| Mar 2, 2010 | Merit 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 |
KRA | K974067 |
| Mar 2, 2010 | Merit 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 |
KRA | K974067 |
| Mar 2, 2010 | Merit 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 |
KRA | K974067 |
| Mar 2, 2010 | Merit 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 |
KRA | K974067 |
| Mar 2, 2010 | Merit 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 |
KRA | K974067 |
| Mar 2, 2010 | Merit 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 |
KRA | K974067 |
| Mar 2, 2010 | Merit 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 |
KRA | K974067 |
| Mar 2, 2010 | Merit 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 |
KRA | K974067 |
| Mar 2, 2010 | Merit 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 |
KRA | K974067 |
| Mar 2, 2010 | Merit 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 |
KRA | K974067 |
| Mar 2, 2010 | Merit 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 |
KRA | K974067 |
| Mar 2, 2010 | Merit 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 |
KRA | K974067 |
| Mar 2, 2010 | Merit 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 |
KRA | K974067 |
| Mar 2, 2010 | Merit 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 |
KRA | K974067 |
| Mar 2, 2010 | Merit 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 |
KRA | K974067 |
| Mar 2, 2010 | Merit 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 |
KRA | K974067 |
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