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)
Mar 2, 2010Merit 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
KRAK974067
Mar 2, 2010Merit 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
KRAK974067
Mar 2, 2010Merit 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
KRAK974067
Mar 2, 2010Merit 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
KRAK974067
Mar 2, 2010Merit 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
KRAK974067
Sep 24, 2009Boston 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
KRAK020012
Sep 24, 2009Boston 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
KRAK000177
Sep 24, 2009Boston 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
KRAK000177
K023681
Aug 25, 2009Edwards 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
KRAK885281
Apr 17, 2009Edwards 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
KRAK924661
Apr 17, 2009Edwards 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
KRAK924661
Apr 17, 2009Edwards 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
KRAK924661
Dec 30, 2008Cordis 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
KRAK983003
Sep 16, 2008EKOS 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
KRAK072507
Sep 11, 2008Merit 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
KRAK992231
Sep 2, 2008EKOS 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
KRAK072507
Aug 20, 2008EKOS 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
KRAK072507
Oct 31, 2007Boston Scientific Corporation
Boston Scientific-Renegade Hi-Flo Microcatheter Kit, UPN Material Number: MOO1183030,Catalog Number: 18-303
Terminated
KRAK000177
Mar 8, 2007Ekos 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
KRAK060422
Nov 14, 2006Boston Scientific Target
Boston Scientific brand Renegade 18 Fiber braided microcatheter, Catalog #: 18257, UPN: M001182570
Terminated
KRAK973645
Nov 1, 2006Boston Scientific Corporation
Renegade Hi-Flo Microcatheter Kits, Catalog/Order # 18-299, UPN M001182990
Terminated
KRAK000177
Sep 2, 2006Cordis Neurovascular, Inc.
Cordis Neurovascular Pre-Shaped Prowler Select Infusion Catheters.
Terminated
KRAK021591
Sep 2, 2006Cordis Neurovascular, Inc.
Cordis Neurovascular Pre-Shaped PROWLER Infusion Catheters.
Terminated
KRAK021591
May 23, 2006Boston 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
KRAK050630
Nov 23, 2005Ekos 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
KRAK042456
Nov 1, 2005Ekos 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
KRAK042456
Nov 1, 2005Ekos 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
KRAK042456
Oct 21, 2005Becton Dickinson Medical Systems
CRITIFLO(tm) FLUSH KIT
Terminated
KRAK791844
Oct 21, 2005Becton Dickinson Medical Systems
CRITIFLO(tm) flush kit.
Terminated
KRAK791844
Oct 21, 2005Becton Dickinson Medical Systems
DT-DL60-1 W/Bifurcated
Terminated
KRAK791844
Oct 21, 2005Becton Dickinson Medical Systems
CRITIFLO(tm) TAK0460 continuous flow catheter
Terminated
KRAK791844
Oct 21, 2005Becton Dickinson Medical Systems
TAKHPQ60R continuous flow catheter.
Terminated
KRAK791844
Oct 21, 2005Becton Dickinson Medical Systems
CRITIFLOW(tm) TA4004 continuous flush catheter
Terminated
KRAK791844
Oct 21, 2005Becton Dickinson Medical Systems
DTX(tm) Plus DT-DL60 Continuous flush catheter
Terminated
KRAK791844
Jul 20, 2004Bacchus 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
KRAK023514
Jul 20, 2004Bacchus 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
KRAK021958
Dec 18, 2003Edwards Lifesciences AG
VAMP Direct Draw, Model VMP700 Needleless cannula for sampling blood.
Terminated
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