FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K962467 |
ABBOTT LABORATORIES |
RV PACING LEAD |
09/17/1996 |
K030556 |
AESCULAP, INC. |
STEELEX ELECTRODE SET |
04/22/2003 |
K960479 |
ARROW INTL., INC. |
ARROW BIPOLAR PACING/BALLOON WEDGE PRESSURE CATHETER |
10/17/1996 |
K955829 |
B. BRAUN MEDICAL, INC. |
SAFPACE SYSTEM |
11/18/1997 |
K160260 |
BIO TRACE MEDICAL, INC. |
Tempo Temporary Pacing Lead |
10/25/2016 |
K971165 |
BOSTON SCIENTIFIC CORP. |
INTRODUCER SHEATH AND DILATOR |
07/23/1997 |
K955712 |
C.R. BARD, INC. |
USCI BIPOLAR BALLOON PACING ELECTRODE WITH BH COATING |
10/11/1996 |
K971775 |
CARDIAC CONTROL SYSTEMS, INC. |
INTERIM AV SHAPED TEMPORARY PACING CATHETER MODEL INT-AV610 |
12/29/1997 |
K955722 |
DAVIS & GECK, INC. |
FLEXON TEMPORARY CARDIAC PACER LEAD |
03/15/1996 |
K152633 |
EDWARDS LIFESCIENCES, LLC |
Chandler Transluminal Bipolar Pacing Probe, Flextip Transluminal Bipolar Pacing Probe |
10/15/2015 |
K980503 |
ETHICON, INC. |
TEMPORARY CARDIAC PACING WIRE |
04/10/1998 |
K173923 |
Ethicon, Inc. |
Temporary Cardiac Pacing Wire |
08/02/2018 |
K033858 |
EUROPEAN CUSTOM MANUFACTURING BV |
TEMPORARY BIPOLAR MYOCARDIAL PACING WIRE |
07/12/2004 |
K963073 |
HARMAC MEDICAL PRODUCTS, INC. |
HARMAC BIPOLAR TEMPORARY PACING CATHETER WITH STYLET |
08/14/1997 |
K962833 |
HARMAC MEDICAL PRODUCTS, INC. |
HARMAC TEMPORARY PACING CATHETER WITH BALLOON |
10/15/1997 |
K190716 |
Medtronic |
Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Atrial Pacing Lead, Streamline 6494 Unipolar Temporary Myocardial Pacing Wire, Streamline 6495 Unipolar Temporary Myocardial Pacing Lead |
08/08/2019 |
K171253 |
Medtronic |
Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Pacing Lead, Streamline 6495 Bipolar Temporary Myocardial Pacing Lead, Streamline 6500 Unipolar Temporary Myocardial Pacing Lead |
05/25/2017 |
K161249 |
Medtronic |
Streamline 6495 Bipolar Temporary Myocardial Pacing Lead |
08/19/2016 |
K040812 |
MEDTRONIC VASCULAR |
DETECT SURGICAL PACING AND MAPPING TOOL |
09/02/2004 |
K973360 |
MEDTRONIC VASCULAR |
MEDTRONIC MODEL 6416 TRANSVENOUS BIPOLAR TEMPORARY PACING LEAD |
05/26/1998 |
K042190 |
MEDTRONIC VASCULAR |
MODEL 6416 TEMPORARY PACING LEAD SYSTEM |
09/07/2004 |
K012454 |
MEDTRONIC VASCULAR |
MODEL 6491 UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD |
08/14/2001 |
K012458 |
MEDTRONIC VASCULAR |
MODEL 6492 UNIPOLAR TEMPORARY ATRIAL PACING LEAD |
08/14/2001 |
K012459 |
MEDTRONIC VASCULAR |
MODEL 6494 UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE |
08/14/2001 |
K012460 |
MEDTRONIC VASCULAR |
MODEL 6495 BIPOLAR TEMPORARY MYOCARDIAL PACING LEAD |
08/14/2001 |
K963898 |
MEDTRONIC VASCULAR |
MODEL 6495 BIPOLAR TEMPORARY PACING LEAD |
07/22/1997 |
K012452 |
MEDTRONIC VASCULAR |
MODEL 6500 UNIPOLAR TEMORARY MYOCARDIAL PACING LEAD |
08/14/2001 |
K961520 |
MEDTRONIC VASCULAR |
UNIPOLAR IPG GROUND CABLE, MODEL 5473 |
11/13/1996 |
K140972 |
MEDTRONIC, INC. |
UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, UNIPOLAR TEMPORARY ATRIAL PACING LEAD, UNIPOLAR TEMPORARY MYOCARDIAL PACING |
06/06/2014 |
K072770 |
Oscor Inc. |
TEMPORARY PACING LEAD, SERIES TBB, MODEL HELIOS (TM) |
01/22/2008 |
K032613 |
PETER M. ROTHENBERG, M.D. |
TEMPORARY TRANSVENOUS PACEMAKER PLACEMENT ASSIST DEVICE |
11/20/2003 |
K023174 |
RIVER MEDICAL, INC. |
DISPOSABLE TEMPORARY PACING WIRE |
06/11/2003 |
K152784 |
ST. JUDE MEDICAL |
Pacel Bipolar Pacing Catheters |
10/22/2015 |
K161873 |
St. Jude Medical |
Pacel Flow Directed Pacing Catheter |
11/22/2016 |
K011660 |
WECK CLOSURE SYSTEMS |
WECK CARDIAC PACING WIRES |
08/21/2001 |
K002603 |
ZCV ,INC. |
ZYNERGY BALLOONPACE BALLOON GUIDED PACING AND MONITORING CATHETER |
01/08/2001 |
K002481 |
ZCV ,INC. |
ZYNERGY FEATHERPACE TRANSVENOUS BIPOLAR CATHETER, MODEL 04-X-02-3-10-3 |
12/07/2000 |
K010099 |
ZCV ,INC. |
ZYNERGY Z3K BALLOON GUIDED PACING AND MONITORING CATHETER |
02/01/2001 |
K002687 |
ZYNERGY CARDIOVASCULAR, INC. |
ZYNERGY Z4 TRANSVENOUS BIPOLAR PACING CATHETER, MODEL 04-X-02-3-10-3 |
11/09/2000 |