FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K190167 |
Abbott |
MitraClip G4 Steerable Guide Catheter |
05/29/2019 |
K221397 |
Abbott Medical |
MitraClip G4 Steerable Guide Catheter |
09/28/2022 |
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 |
K211100 |
Acutus Medical, Inc. |
AcQGuide MAX Steerable Sheath |
05/14/2021 |
K162925 |
ACUTUS MEDICAL, INC. |
AcQGuide Steerable Sheath |
04/06/2017 |
K221044 |
Acutus Medical, Inc. |
AcQGuide« VUE Steerable Sheath |
05/05/2022 |
K223824 |
Boston Scientific Corporation |
POLARSHEATHÖ Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAPÖ Circular Mapping Catheter (UPN:M004CRBS7210), POLARMAPÖ EP Electrical Cable (UPN:M004CRBS62000), SMARTFREEZEÖ Esophageal Temperature Sensor (ETS) Cable: -SMARTFREEZEÖ Esophageal Temperature S |
03/22/2023 |
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 |
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 |
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 |
K192422 |
Freudenberg Medical LLC |
Steerable Introducer 12F |
10/04/2019 |
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 |
K183174 |
Medtronic CryoCath LP |
FlexCath Advance Steerable Sheath and Dilator |
11/26/2018 |
K202620 |
Medtronic CryoCath LP |
FlexCath Advance Steerable Sheath and Dilator |
11/13/2020 |
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 |