Biotronik, Inc.
FDA 510(k) medical device clearances.
Top product codes for Biotronik, Inc.
Recent clearances by Biotronik, Inc.
- K250706 — Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter
- K242969 — Pantera Pro; Pantera LEO
- K240787 — Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool (383119); Selectra Accessory Kit (375518)
- K241711 — Oscar Peripheral Multifunctional Catheter system
- K230375 — BIOMONITOR IV
- K222065 — Passeo-35 Xeo Peripheral Dilatation Catheter
- K221856 — BIOMONITOR IIIm, BIOMONITOR III
- K222037 — Selectra Lead Implantation System
- K214038 — Oscar Peripheral Multifunctional Catheter system
- K201445 — MultiCath, AcQRate Dx Fixed Curve Catheter
- K201865 — Biomonitor III, Biomonitor IIIm
- K193474 — Selectra 3D Outer Guiding Catheters
- K200444 — Biomonitor III, Biomonitor IIIm
- K192996 — Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool
- K191469 — Biotronik Stylets
- K190548 — BIOMONITOR III, Remote Assistant III
- K183265 — Selectra Catheters, Selectra Accessory Kit
- K171514 — BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, Set
- K170628 — BioMonitor 2-AF, BioMonitor 2-S
- K163660 — Pantera LEO
- K160985 — Pantera Pro
- K152995 — BioMonitor 2-AF, BioMonitor 2-S
- K151744 — Passeo-18 Peripheral Dilation Catheter
- K152240 — Passeo-14 Peripheral Dilatation Catheter
- K151409 — Selectra Catheters and Selectra Accessory Kit
- K143503 — BioMonitor
- K142379 — Passeo-35 PTA Catheter
- K132960 — BIOMONITOR
- K131978 — SELECTRA ACCESSORY KIT, SELECTRA SLITTER TOOL
- K130161 — PASSEO-35
- K123324 — SELECTRA 7F CATHETERS
- K111839 — SELECTRA ACCESSORY KIT
- K112482 — SELECTRA SLITTER TOOL
- K111154 — SELECTRA IC-50-60, SELECTRA IC-50-75, SELECTRA IC-90-65, SELECTRA IC-90-75
- K110461 — SELECTRA CS LEAD INTRODUCER SYSTEM
- K101776 — SCOUTPRO ACS
- K101282 — SCOUTPRO HEMOSTATIC VALVE
- K093303 — SCOUTPRO 7F LONG CATHETERS
- K083674 — PK-141 PATIENT CABLE
- K082935 — VISION WIRE CORONARY GUIDEWIRE
- K082933 — PASSEO-35 PTA CATHETER
- K080988 — SCOUTPRO CS LEAD INTRODUCER SYSTEM
- K072329 — SCOUTPRO 8F, 7F AND SLITTER TOOL ADVANCED
- K073230 — MODELS ERA 300 AND 3105 PACING SYSTEM ANALYZERS
- K072765 — PASSEO 18
- K071665 — SCOUTPRO SLITTER TOOL ADVANCED, MODEL 356 552
- K061212 — BIOTRONIK ENDOCARDIAL PACING LEADS
- K060807 — SCOUTPRO 7F CORONARY SINUS LEAD DELIVERY SYSTEM
- K060655 — SCOUTPRO 8F, MODELS 342 262; HEMOSTATIC VALVE, MODELS 345 968; HOOK GUIDING CATHETER, MODELS 342 263; MULTI-PURPOSE H
- K042373 — GALEO FOCUS GUIDE WIRE
- K042708 — ERA 3000 PACING SYSTEM ANALYZER
- K033613 — MODIFICATION TO ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER
- K033320 — SCOUT PRO
- K033217 — PHERON PTA CATHETER
- K023205 — ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BP
- K022360 — 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.
- K023803 — MODIFICATION TO BIOTRONIK'S STERILIZATION PROCESS
- K023099 — AROX 45-JBP; AROX 53-JBP; MEROX 45-JBP; MEROX 53-JBP
- K020821 — SCOUT (SINUS CORNARIUS UTILITY TOOL), MODEL 335 117
- K021217 — AROX 53-BP; AROX 60-BP; AROX 45-JBP; AROX 53-JBP
- K010281 — MEROX BIPOLAR HIGH IMPEDANCE LEAD MODELS: MEX 53/13-BP; 60/15-BP; 45-JBP; 53-JBP
- K003454 — A1-CS-SB Y-ADAPTER, MODEL 124 871
- K003072 — PACING LEADS, GUIDE WIRES, AND VARIOUS ACCESSORIES
- K001736 — GALEO HYDRO AND GALEO HYDRO J-TIP
- K001413 — ELOX 45-BP, MODEL 330 132, EFH-27, MODEL 331 549, EXTENSION TOOL, MODEL 331 668
- K994240 — EX 45-BP, MODEL 330 132; EX 53-BP, MODEL 130 018; EX 60-BP, MODEL 330 133
- K993139 — YP 45/15-BP; YP 53/15-BP; YP 60/15-BP
- K993434 — PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-A
- K991169 — SX 53/15-BP, MODEL 124 853, SX 60/15-BP, MODEL 124 854
- K990483 — RETROX RX 45-JBP 124774, 53-JBP 124775, 53-BP 124776, 60-124777
- K982272 — 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
- K980869 — SYNOX SX 53-BP, SX 60-BP, SX 45-JBP, SX 53-JBP , MODELS 120 444, 119 684, 120 438 AND 120 143
- K981083 — 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
- K972500 — TIR/TIJ AND POLYROX
- K965106 — ELC 35-UP MODEL NUMBER 116015 AND ELC 54-UP MODEL NUMBER 115606
- K970388 — A1-A,ABP,B,MBP, LEAD CONNECTORS; PEH ADAPTER SLEEVE
- K971930 — BK-N SEALING CAP
- K964190 — ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER
- K970204 — BK-A; BK-B; BK-IS SEALING CAP
- K964604 — BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEADS, WITH SILICONE RUBBER INSULATION AND PASSIVE FIXATION
- K953044 — UNIPOLAR & BIOPLAR IMPLANTABLE ENDOCARDIAL PACING LEADS, WITH SILICONE RUBBER INSULATION & PASSIVE FIXATION
- K945627 — PIKOS LP 01, PIKOS LP E01
- K952328 — NANOS, PIKOS 01/E01, 01-A, E01-B, LP 01/LP E01
- K941937 — PIKOS E 01-B
Data sourced from openFDA. This site is unofficial and independent of the FDA.