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) |
|---|---|---|---|
| Mar 2, 2010 | Merit Medical Systems, Inc. Mistique Infusion Catheter, MIC5-90-10-035, 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, MIC5-90-10-038, 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, MIC5-90-20-035, 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, MIC5-90-20-038, 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, MIC5-90-5-035, 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 |
| Sep 24, 2009 | Boston Scientific Corporation Boston Scientific, Renegade Fiber Braided Microcatheter, Peripheral Vascular Use, RX Only, Sterilized using ethylene oxide, Legal Manufacturer: Boston Scientific Cork Ltd., Business & Technology Park Terminated |
KRA | K020012 |
| Sep 24, 2009 | Boston Scientific Corporation Boston Scientific Renegade" Hi Flo Microcatheter (neurovascular use) REF 18-288OUS, Sterilized using ethylene oxide, Legal Manufacturer, Boston Scientific Corporation, One Boston Scientific Place, Na Terminated |
KRA | K000177 |
| Sep 24, 2009 | Boston Scientific Corporation Boston Scientific Renegade" Hi-Flo Microcatheter, Peripheral Vascular Use. Sterilized with Ethylene Oxide. Legal Manufacturer: Boston Scientific Cork Ltd., Business & Technology Park, Model Farm R Terminated |
KRA | K000177 K023681 |
| Aug 25, 2009 | Edwards Lifesciences AG Edwards Lifesciences "VAMP Jr" (Venous Arterial blood Management Protection system), Lot numbers (all product manufactured between 8/01/06 and 2/29/08.) Terminated |
KRA | K885281 |
| Apr 17, 2009 | Edwards Lifesciences, Llc Edwards Lifesciences Swan-Ganz Thermodilution Catheter with AMC THROMBOSHIELD (An Antimicrobial * Heparin Coating)
REF: 139HF75P
For use inpatients who require hemodynamic monitoring. Intended to be Terminated |
KRA | K924661 |
| Apr 17, 2009 | Edwards Lifesciences, Llc Edwards Lifesciences Swan-Ganz Intellicath CCO/VIP Thermodilution Catheter with AMC Thromboshield (an Antimicrobial *Heparin Coating) For use with Vigilance Monitor. REF: 139HF75
For use inpatients Terminated |
KRA | K924661 |
| Apr 17, 2009 | Edwards Lifesciences, Llc Edwards Lifesciences Swan-Ganz Thermodilution Catheter REF: 139F75
For use inpatients who require hemodynamic monitoring. Intended to be used in combination with clinical pressure monitoring equipme Terminated |
KRA | K924661 |
| Dec 30, 2008 | Cordis Corporation MassTRANSIT Infusion Catheter Kit, 605-731K & 605-780K, Cordis Neurovascular
Intended to be used as a mechanism for the infusion of various diagnostic, embolic, and therapeutic agents into the Neurov Terminated |
KRA | K983003 |
| Sep 16, 2008 | EKOS Corporation EKOS EndoWave Infusion System consisting of a Drug Delivery Catheter and an Ultrasound Core. Labeled as Sterile, Single Use Only. The device is intended for the controlled and selective infusion of Terminated |
KRA | K072507 |
| Sep 11, 2008 | Merit Medical Systems, Inc. Fountain Infusion System, 4F, REF IS4-90-50, Sterile, Merit Medical Systems, Inc., South Jordan, Utah 84095. Continuous flush catheter intended to administer infusions of various therapeutic solution Terminated |
KRA | K992231 |
| Sep 2, 2008 | EKOS Corporation PT-3B Control Unit - component of the EndoWave Infusion Catheter System. EndoWave Infusion System consists of three main components, a single use EndoWave Infusion Catheter System which is comprised Terminated |
KRA | K072507 |
| Aug 20, 2008 | EKOS Corporation Infusion System. EKOS EndoWave Infusion System. EKOS EndoWave Infusion System Drug Delivery Catheter with Ultrasound Core. Labeled as Sterile, Single Use Only. Connector clip is CIC Connector Clip. Terminated |
KRA | K072507 |
| Oct 31, 2007 | Boston Scientific Corporation Boston Scientific-Renegade Hi-Flo Microcatheter Kit,
UPN Material Number: MOO1183030,Catalog Number: 18-303 Terminated |
KRA | K000177 |
| Mar 8, 2007 | Ekos Corp EKOS EndoWave Infusion System and EKOS Lysus Infusion Systems - drug delivery catheters. EKOS Corporation Bothell, WA
Packaging: *EndoWave(TM) Ultrasound Accelerated Thrombolysis (USAT) EKOS Endo Terminated |
KRA | K060422 |
| Nov 14, 2006 | Boston Scientific Target Boston Scientific brand Renegade 18 Fiber braided microcatheter, Catalog #: 18257, UPN: M001182570 Terminated |
KRA | K973645 |
| Nov 1, 2006 | Boston Scientific Corporation Renegade Hi-Flo Microcatheter Kits, Catalog/Order # 18-299, UPN M001182990 Terminated |
KRA | K000177 |
| Sep 2, 2006 | Cordis Neurovascular, Inc. Cordis Neurovascular Pre-Shaped Prowler Select Infusion Catheters. Terminated |
KRA | K021591 |
| Sep 2, 2006 | Cordis Neurovascular, Inc. Cordis Neurovascular Pre-Shaped PROWLER Infusion Catheters. Terminated |
KRA | K021591 |
| May 23, 2006 | Boston Scientific Target Boston Scientific brand Pivot Steerable Microcatheter, 1.9F/2.4F,
Catalog #: 1721, Universal Product Number: M00317210,
Product is Manufactured by: Boston Scientific - Precision Vascular, 2405 West Terminated |
KRA | K050630 |
| Nov 23, 2005 | Ekos Corp Lysus Infusion System - PT-3 Control . The Lysus Infusion System employs high frequency (2-2.5 MHz), low power (0.45 watt average power per transducer) ultrasound to facilitate the delivery of physic Terminated |
KRA | K042456 |
| Nov 1, 2005 | Ekos Corp Lysus Infusion System - Lysus Drug Delivery Catheter: The Lysus Infusion System employs high frequency (2-2.5 MHz), low power (0.45 watt average power per transducer) ultrasound to facilitate the d Terminated |
KRA | K042456 |
| Nov 1, 2005 | Ekos Corp The Lysus Infusion System - Catheter Interface Cable. The Lysus Infusion System employs high frequency (2-2.5 MHz), low power (0.45 watt average power per transducer) ultrasound to facilitate the del Terminated |
KRA | K042456 |
| Oct 21, 2005 | Becton Dickinson Medical Systems CRITIFLO(tm) FLUSH KIT Terminated |
KRA | K791844 |
| Oct 21, 2005 | Becton Dickinson Medical Systems CRITIFLO(tm) flush kit. Terminated |
KRA | K791844 |
| Oct 21, 2005 | Becton Dickinson Medical Systems DT-DL60-1 W/Bifurcated Terminated |
KRA | K791844 |
| Oct 21, 2005 | Becton Dickinson Medical Systems CRITIFLO(tm) TAK0460 continuous flow catheter Terminated |
KRA | K791844 |
| Oct 21, 2005 | Becton Dickinson Medical Systems TAKHPQ60R continuous flow catheter. Terminated |
KRA | K791844 |
| Oct 21, 2005 | Becton Dickinson Medical Systems CRITIFLOW(tm) TA4004 continuous flush catheter Terminated |
KRA | K791844 |
| Oct 21, 2005 | Becton Dickinson Medical Systems DTX(tm) Plus DT-DL60 Continuous flush catheter Terminated |
KRA | K791844 |
| Jul 20, 2004 | Bacchus Vascular Inc Bacchus brand Trellis Reserve, Peripheral Infusion System, 6.0 Fr
Catalog Numbers:
BAC TRE 06 100 10,
BAC TRE 06 100 20,
BAC TRE 06 140 10,
BAC TRE 06 140 20 Terminated |
KRA | K023514 |
| Jul 20, 2004 | Bacchus Vascular Inc Bacchus brand Trellis Plus, Peripheral Infusion System, 6.0 Fr
Catalog Numbers:
BAC TRR 006 140 10,
BAC TRR 006 140 20 Terminated |
KRA | K021958 |
| Dec 18, 2003 | Edwards Lifesciences AG VAMP Direct Draw, Model VMP700
Needleless cannula for sampling blood. Terminated |
KRA | None listed |
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