FDA 510(k) Applications Submitted by Jon Brumbaugh
FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
K130161 |
01/23/2013 |
PASSEO-35 |
BIOTRONIK, INC. |
K010281 |
01/30/2001 |
MEROX BIPOLAR HIGH IMPEDANCE LEAD MODELS: MEX 53/13-BP; 60/15-BP; 45-JBP; 53-JBP |
BIOTRONIK, INC. |
K230375 |
02/13/2023 |
BIOMONITOR IV |
BIOTRONIK, Inc. |
K990483 |
02/16/1999 |
RETROX RX 45-JBP 124774, 53-JBP 124775, 53-BP 124776, 60-124777 |
BIOTRONIK, INC. |
K110461 |
02/17/2011 |
SELECTRA CS LEAD INTRODUCER SYSTEM |
BIOTRONIK, INC. |
K200444 |
02/24/2020 |
Biomonitor III, Biomonitor IIIm |
BIOTRONIK, Inc. |
K170628 |
03/02/2017 |
BioMonitor 2-AF, BioMonitor 2-S |
BIOTRONIK, Inc |
K190548 |
03/05/2019 |
BIOMONITOR III, Remote Assistant III |
Biotronik, Inc. |
K000763 |
03/09/2000 |
PX 53/15-BP, MODEL 130 050 AND PX 60/15-BP, MODEL 130 051 |
BIOTRONIK, GMBH & CO. |
K020821 |
03/13/2002 |
SCOUT (SINUS CORNARIUS UTILITY TOOL), MODEL 335 117 |
BIOTRONIK, INC. |
K060655 |
03/13/2006 |
SCOUTPRO 8F, MODELS 342 262; HEMOSTATIC VALVE, MODELS 345 968; HOOK GUIDING CATHETER, MODELS 342 263; MULTI-PURPOSE H |
BIOTRONIK, INC. |
K060807 |
03/24/2006 |
SCOUTPRO 7F CORONARY SINUS LEAD DELIVERY SYSTEM |
BIOTRONIK, INC. |
K991169 |
04/07/1999 |
SX 53/15-BP, MODEL 124 853, SX 60/15-BP, MODEL 124 854 |
BIOTRONIK, INC. |
K080988 |
04/07/2008 |
SCOUTPRO CS LEAD INTRODUCER SYSTEM |
BIOTRONIK, INC. |
K160985 |
04/08/2016 |
Pantera Pro |
BIOTRONIK, INC |
K021217 |
04/17/2002 |
AROX 53-BP; AROX 60-BP; AROX 45-JBP; AROX 53-JBP |
BIOTRONIK, INC. |
K111154 |
04/25/2011 |
SELECTRA IC-50-60, SELECTRA IC-50-75, SELECTRA IC-90-65, SELECTRA IC-90-75 |
BIOTRONIK, INC. |
K061212 |
05/01/2006 |
BIOTRONIK ENDOCARDIAL PACING LEADS |
BIOTRONIK, INC. |
K001413 |
05/04/2000 |
ELOX 45-BP, MODEL 330 132, EFH-27, MODEL 331 549, EXTENSION TOOL, MODEL 331 668 |
BIOTRONIK, INC. |
K101282 |
05/06/2010 |
SCOUTPRO HEMOSTATIC VALVE |
BIOTRONIK, INC. |
K171514 |
05/24/2017 |
BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, Set |
BIOTRONIK, Inc. |
K151409 |
05/26/2015 |
Selectra Catheters and Selectra Accessory Kit |
BIOTRONIK, INC. |
K201445 |
06/01/2020 |
MultiCath, AcQRate Dx Fixed Curve Catheter |
Biotronik, Inc |
K191469 |
06/03/2019 |
Biotronik Stylets |
Biotronik, Inc |
K001736 |
06/07/2000 |
GALEO HYDRO AND GALEO HYDRO J-TIP |
BIOTRONIK, INC. |
K071665 |
06/18/2007 |
SCOUTPRO SLITTER TOOL ADVANCED, MODEL 356 552 |
BIOTRONIK, INC. |
K101776 |
06/25/2010 |
SCOUTPRO ACS |
BIOTRONIK, INC. |
K221856 |
06/27/2022 |
BIOMONITOR IIIm, BIOMONITOR III |
BIOTRONIK, Inc. |
K131978 |
06/28/2013 |
SELECTRA ACCESSORY KIT, SELECTRA SLITTER TOOL |
BIOTRONIK, INC. |
K111839 |
06/29/2011 |
SELECTRA ACCESSORY KIT |
BIOTRONIK, INC. |
K151744 |
06/29/2015 |
Passeo-18 Peripheral Dilation Catheter |
BIOTRONIK, INC. |
K201865 |
07/06/2020 |
Biomonitor III, Biomonitor IIIm |
Biotronik, Inc. |
K222037 |
07/11/2022 |
Selectra Lead Implantation System |
Biotronik, Inc. |
K222065 |
07/13/2022 |
Passeo-35 Xeo Peripheral Dilatation Catheter |
BioTronik, Inc. |
K022360 |
07/19/2002 |
ERA 3000; PA-2 IS-1 ADAPTER; EK-4-N PACEMAKER TEST CABLE; ERA 3000 CHARGER; ERA 3000 BATTERY (TYPE 2); NK-11 POWER SUPP. |
BIOTRONIK, INC. |
K152240 |
08/10/2015 |
Passeo-14 Peripheral Dilatation Catheter |
BIOTRONIK, INC. |
K212593 |
08/16/2021 |
ViaCath, AcQRate Dx Steerable Catheter |
Biotronick, Inc. |
K072329 |
08/20/2007 |
SCOUTPRO 8F, 7F AND SLITTER TOOL ADVANCED |
BIOTRONIK, INC. |
K142379 |
08/26/2014 |
Passeo-35 PTA Catheter |
BIOTRONIK, INC. |
K112482 |
08/29/2011 |
SELECTRA SLITTER TOOL |
BIOTRONIK, INC. |
K042373 |
09/01/2004 |
GALEO FOCUS GUIDE WIRE |
BIOTRONIK, INC. |
K023099 |
09/18/2002 |
AROX 45-JBP; AROX 53-JBP; MEROX 45-JBP; MEROX 53-JBP |
BIOTRONIK, INC. |
K993139 |
09/20/1999 |
YP 45/15-BP; YP 53/15-BP; YP 60/15-BP |
BIOTRONIK, INC. |
K132960 |
09/20/2013 |
BIOMONITOR |
BIOTRONIK, INC. |
K023205 |
09/25/2002 |
ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BP |
BIOTRONIK, INC. |
K072765 |
09/28/2007 |
PASSEO 18 |
BIOTRONIK, INC. |
K042708 |
09/30/2004 |
ERA 3000 PACING SYSTEM ANALYZER |
BIOTRONIK, INC. |
K052757 |
09/30/2005 |
PHERON PERIPHERAL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER |
BIOTRONIK AG |
K082935 |
10/01/2008 |
VISION WIRE CORONARY GUIDEWIRE |
BIOTRONIK, INC. |
K082933 |
10/01/2008 |
PASSEO-35 PTA CATHETER |
BIOTRONIK, INC. |
K003072 |
10/03/2000 |
PACING LEADS, GUIDE WIRES, AND VARIOUS ACCESSORIES |
BIOTRONIK, INC. |
K033217 |
10/03/2003 |
PHERON PTA CATHETER |
BIOTRONIK, INC. |
K993434 |
10/12/1999 |
PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-A |
BIOTRONIK, INC. |
K152995 |
10/13/2015 |
BioMonitor 2-AF, BioMonitor 2-S |
BIOTRONIK, INC. |
K033320 |
10/15/2003 |
SCOUT PRO |
BIOTRONIK, INC. |
K093303 |
10/21/2009 |
SCOUTPRO 7F LONG CATHETERS |
BIOTRONIK, INC. |
K123324 |
10/26/2012 |
SELECTRA 7F CATHETERS |
BIOTRONIK, INC. |
K192996 |
10/28/2019 |
Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool |
Biotronik, Inc |
K023803 |
11/14/2002 |
MODIFICATION TO BIOTRONIK'S STERILIZATION PROCESS |
BIOTRONIK, INC. |
K073230 |
11/15/2007 |
MODELS ERA 300 AND 3105 PACING SYSTEM ANALYZERS |
BIOTRONIK, INC. |
K033613 |
11/17/2003 |
MODIFICATION TO ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER |
BIOTRONIK, INC. |
K183265 |
11/23/2018 |
Selectra Catheters, Selectra Accessory Kit |
Biotronik, Inc. |
K143503 |
12/10/2014 |
BioMonitor |
BIOTRONIK, INC. |
K083674 |
12/11/2008 |
PK-141 PATIENT CABLE |
BIOTRONIK, INC. |
K994240 |
12/16/1999 |
EX 45-BP, MODEL 330 132; EX 53-BP, MODEL 130 018; EX 60-BP, MODEL 330 133 |
BIOTRONIK, INC. |
K193474 |
12/16/2019 |
Selectra 3D Outer Guiding Catheters |
BIOTRONIK, Inc |
K214038 |
12/23/2021 |
Oscar Peripheral Multifunctional Catheter system |
BIOTRONIK, Inc. |
K163660 |
12/27/2016 |
Pantera LEO |
BIOTRONIK, INC. |
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