FDA 510(k) Applications Submitted by BioTronik, Inc.

FDA 510(k) Number Submission Date Device Name Applicant
K980869 03/06/1998 SYNOX SX 53-BP, SX 60-BP, SX 45-JBP, SX 53-JBP , MODELS 120 444, 119 684, 120 438 AND 120 143 BIOTRONIK, INC.
K982272 06/29/1998 GALEO HS 014 MODEL 117 130, GALEO S 014 MODEL 115 488, GALEAO M 014 MODEL 114156, GALEO F 014 MODEL 115 487 GALEO HF 018 BIOTRONIK, INC.
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.
K190548 03/05/2019 BIOMONITOR III, Remote Assistant III Biotronik, Inc.
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.
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.
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.
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.
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.
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.
K214038 12/23/2021 Oscar Peripheral Multifunctional Catheter system BIOTRONIK, Inc.
K163660 12/27/2016 Pantera LEO BIOTRONIK, INC.
K003454 11/07/2000 A1-CS-SB Y-ADAPTER, MODEL 124 871 BIOTRONIK, INC.
K953044 06/30/1995 UNIPOLAR & BIOPLAR IMPLANTABLE ENDOCARDIAL PACING LEADS, WITH SILICONE RUBBER INSULATION & PASSIVE FIXATION BIOTRONIK, INC.
K970204 01/21/1997 BK-A; BK-B; BK-IS SEALING CAP BIOTRONIK, INC.
K970388 02/03/1997 A1-A,ABP,B,MBP, LEAD CONNECTORS; PEH ADAPTER SLEEVE BIOTRONIK, INC.
K964190 10/21/1996 ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER BIOTRONIK, INC.
K965106 12/20/1996 ELC 35-UP MODEL NUMBER 116015 AND ELC 54-UP MODEL NUMBER 115606 BIOTRONIK, INC.
K964604 11/18/1996 BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEADS, WITH SILICONE RUBBER INSULATION AND PASSIVE FIXATION BIOTRONIK, INC.
K971930 05/27/1997 BK-N SEALING CAP BIOTRONIK, INC.
K981083 03/24/1998 RETROX RX 53-BP, RETROX RX 60-BP, RETROX RX 45-JBP, RETROX RX 53-JBP MODEL NUMBERS 124 396, 124 397, 124 395, 124 000 BIOTRONIK, INC.
K972500 07/03/1997 TIR/TIJ AND POLYROX BIOTRONIK, INC.
K945627 11/16/1994 PIKOS LP 01, PIKOS LP E01 BIOTRONIK, INC.


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