FDA 510(k) Applications for Medical Device Product Code "DRA"
(Catheter, Steerable)

FDA 510(k) Number Applicant Device Name Decision Date
K161985 ABBOTT VASCULAR Steerable Guide Catheter 08/07/2016
K172394 Abbott Vascular Steerable Guide Catheter 09/06/2017
K112239 Abbott Vascular STEERABLE GUIDE CATHETER 08/31/2011
K162925 ACUTUS MEDICAL, INC. AcQGuide Steerable Sheath 04/06/2017
K152310 CARDIOFOCUS, INC. HeartLight Deflectable Sheath 02/24/2016
K120086 CARDIOSOLUTIONS CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODCER 65CM CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCER 80CM 04/24/2012
K900320 CATHETER RESEARCH C/O BURDITT, BOWLES & RADZIUS CRI CYNOSAR CATHETER 09/14/1990
K904785 CATHETER RESEARCH C/O BURDITT, BOWLES & RADZIUS CRI CYNOSAR CATHETER 03/06/1991
K924227 CATHETER RESEARCH C/O BURDITT, BOWLES & RADZIUS CRI CYNOSAR CATHETER 06/29/1993
K884337 CATHETER RESEARCH C/O BURDITT, BOWLES & RADZIUS MICRO-GUIDE SYSTEM 01/05/1989
K070357 CRYOCATH TECHNOLOGIES, INC. FLEXCATH STEERABLE SHEATH & DILATOR 12/28/2007
K081049 CRYOCATH TECHNOLOGIES, INC. FLEXCATH STEERABLE SHEATH & DILATOR, MODELS 3FC10, 3FC12 06/27/2008
K913940 DAIG CORP. RESPONSE(TM) STEERABLE CATHETER 01/26/1993
K834352 DLP, INC. ADULT VENT CATHETER 01/27/1984
K050472 EKOS CORP. LYSUS INFUSION SYSTEM 03/11/2005
K093866 EVALVE INC EVALVE STEERABLE GUIDE CATHETER 01/13/2010
K091596 EVALVE INC EVALVE STEERABLE GUIDE CATHETER, MODEL SGC01ST 07/02/2009
K100789 EVALVE INC MODIFICATON TO: STEERABLE GUIDE CATHETER, MODEL SGC01ST 04/21/2010
K083793 EVALVE INC STEERABLE GUIDE CATHETER 04/27/2009
K112541 Greatbatch Medical Z FLEX-270TM STEERABLE SHEATH 02/07/2012
K122275 Hansen Medical ARTISAN EXTEND CONTROL CATHETER 08/29/2012
K133552 Hansen Medical MAGELLAN ROBOTIC CATHETER 6FR (GUIDE AND LEADER), MAGELLAN ROBOTIC CATHETER 6FR ACCESSORY KIT 02/07/2014
K151463 HANSEN MEDICAL, INC. Hansen Medical Magellan Robotic Catheter 6Fr and Accessory Components 08/18/2015
K160919 HANSEN MEDICAL, INC. Hansen Medical Magellan Robotic Catheter 9Fr 09/20/2016
K153304 Hansen Medical, Inc. Hansen Medical Magellan Robotic Catheter eKit 02/01/2016
K012143 MEDTRONIC CARDIAC SURGICAL PRODUCTS 24 FR. LEFT HEART VENT CATHETER WITH PRESSURE MONITORING LINE, MODEL 12524 10/24/2001
K123591 MEDTRONIC CRYOCATH LP FLEXCATH ADVANCE STEERABLE SHEATH (12 FRENCH) 12/27/2012
K102176 MEDTRONIC CRYOCATH LP FLEXCATH STEERABLE SHEATH (12 FRENCH), FLEXCATH STEERABLE SHEATH (10 FRENCH) MODEL 3FC12, 3FC10 09/01/2010
K052575 ST. JUDE MEDICAL LUMINARY CANNULATOR BIDEFLECTABLE CATHETER WITH LUMEN 01/19/2006
K040165 ST. JUDE MEDICAL REFLEXION CANNULATOR STEERABLE ELECTROPHYSIOLOGY CATHETER WITH LUMEN, MODEL 402805 05/12/2004


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