BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BIOTRONIK, INC.

    Reg #: 1028232 · FEI: 1028232 · Expires 2026
    View on FDA
    Products
    25
    Proprietary Names
    260
    Establishment Types
    1
    Classifications
    25

    Registration Details

    Registration Name
    BIOTRONIK, INC.
    Registration Number
    1028232
    FEI Number
    1028232
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    6024 JEAN RD.
    City
    LAKE OSWEGO
    State
    OR
    ZIP
    97035
    Country
    US

    Regulatory Submissions

    510(k) Number
    K151409
    PMA Number
    P980023

    Owner / Operator

    Firm Name
    BIOTRONIK, INC.
    Operator Number
    1028232
    Address
    6024 JEAN RD., --
    City
    Lake Oswego
    State
    OR
    Postal Code
    97035
    Country
    US
    Correspondent
    JON - BRUMBAUGH

    Products

    Device Name Product Code
    Catheter, Percutaneous DQY
    Pacemaker Lead Adaptor DTD
    Pulse-Generator, Pacemaker, External DTE
    Tester, Pacemaker Electrode Function DTA
    Permanent Defibrillator Electrodes NVY
    Programmer, Pacemaker KRG
    Implantable Cardioverter Defibrillator (Non-Crt) LWS
    Permanent Pacemaker Electrode DTB
    Implantable Pulse Generator, Pacemaker (Non-Crt) LWP
    Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) NIK
    Pulse Generator, Permanent, Implantable NVZ
    Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) NKE
    Implantable Pacemaker Pulse-Generator DXY
    Pacemaker/Icd/Crt Non-Implanted Components OSR
    Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes NVN
    Pulse Generator, External Pacemaker, Dual Chamber OVJ
    Wire, Guide, Catheter DQX
    Catheter, Angioplasty, Peripheral, Transluminal LIT
    Catheters, Transluminal Coronary Angioplasty, Percutaneous LOX
    Stylet, Catheter DRB
    Catheter, Electrode Recording, Or Probe, Electrode Recording DRF
    Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection) MXD
    Analyzer, Pacemaker Generator Function DTC
    Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode OJX
    Defibrillator, Implantable, Dual-Chamber MRM

    Proprietary Names

    BK-N Linoxsmart PSW 1301.U Protego S-65 IS1-C5PS PA-10 Si-2 DH DF4 TW PA-11 PA-4 VL S 60 BSDF-1 COV DF1-C6HV S-75 PK-44 EFH BK-IS4/DF4 SI-8 IS4/DF4 Adapter Plexa Plexa ProMRI S DX Plexa ProMRI 60 cm Renamic D-KIT D2-KIT ICS 3000 Volta Vigila Linox Kainox VCS Pamira HMSC Version 3.63 Solox HMSC Version 3.64 CardioMessenger Home Monitoring HMSC Version 3.65 S 45 Entovis DH S 58 S 53 NK-29 PK-155 PK-222 PK-175 BS IS-1 Blind Plug Eluna PK-83 Etrinsa PSW 1506.U Solia Evity PSW 1702.U PSW 1507.U Safio PSW 1506.U/1 PSW 1703.U Edora EFH-6F-W PSW 1704.U HMSC Version 3.39 PSW 1801.U HMSC Version 3.40 HMSC Version 3.41 HMSC Version 3.44 Solia T/JT PSW 1804.U HMSC Version 3.43 HMSC Version 3.42 PSW 1901.U HMSC Version 3.45 PSW 1904.U HMSC Version 3.47 PK-155-B HMSC Version 3.48 PK-222-L ECG Cable NEO 2100.U PSW 2100.U NEO 2201.U/1 PSW 2100.U/1 HMSC Version 3.54 HMSC Version 3.53 Selox Renamic Neo Programmer PSW 2202.U PSW 2201.U/1 Estella EDP HMSC Version 3.57 NEO 2302.U Model 6652 Solvia NEO 2303.U Model 3150 Setrox S Model 3171 NEO 2401.U Ecuro Tilda Effecta PSW 2302.U Evia PSW 2303.U HMSC Version 3.58 Model 6653 NEO 2202.U Model 3145 Model 6646 NEO 2301.U Model 3175 PSW 2301.U Dextrus Reliaty Reocor HMSC Version 3.64.1 HMSC 3.55 NEO 2204.U P-KIT Amvia PSW 2204.U M-50 Magnet PSW 2401.U NEO 2401.U/1 Renamic Neo NEOexpress Solia CSP S 60 HMSC Version 3.60 HMSC Version 3.62 HMSC Version 3.65.1 Solia CSP S 53 Streamer Polymer Guidewire Pantera LEO Oscar Multifunctional Catheter System Pantera Pro Passeo-14 Passeo-18 Passeo-35 Xeo BK-IS BK-A BK-B S 60-J S 60-K S 60-S S 45-J S 45-JL S 85-K OTW S 65-A S 75-A S 45-S S 45-F S 75-K OTW S 45-K S 60-F S 60-C S 75-G OTW S 65-E S 75-C S 65-K S 85-G OTW S 53-K S 53-S S 75-E S 65-C S 53-J S 53-JL S 53-F S 75-K MPK-4-R MPK-10-R MultiCath AcQRate DX Fixed Curve Catheter BIOMONITOR IIIm Patient App version 2.2 BIOMONITOR III Patient App 2.4.1 Patient App 2.7 Patient App 2.5 VisionWire ACD 300 PK-67 ERA-P ERA 300-B AKKU-1 NK-9 ERA 300 Biomonitor BIOMONITOR IV A1-CS-SB Selectra 3D-55-39 Selectra 3D-65-39 Selectra 3D-65-42 Selectra 3D-55-42 Selectra 3D-40-32 Selectra 3D-40-39 Selectra 3D-65-32 Selectra 3D-40-42 Selectra 3D-55-32 Selectra Lead Introducer System PK-141 Patient Cable Remote Assistant III Patient App Version 2.8 Patient App Version 2.9 Acticor Sky Rivacor Sky/Rise/Aura Iforia Ilesto Itrevia DF4 Ilesto DF4 Iforia DF4 Iperia HF-T QP Itrevia Inventra Iperia DF4 Inventra DF4 Inventra HF-T QP Iperia Itrevia HF-T QP Intica BS IS4 Ilivia Acticor family Lumax AcQRate Dx Steerable Catheter ViaCath BioMonitor 2-AF BioMonitor 2-S FIT - Fast Insert Tool 1 + 2, Set Remote Assistant Selectra IC – 90 – 69 Selectra IC – 90 – 59 Selectra IC – 50 – 59 Selectra MPEP – 45 Selectra Straight – 45 Selectra Accessory Kit Selectra Extended Hook – 55 Selectra Straight – 55 Selectra BIO2 – 45 Selectra Multipurpose Hook – 45 Selectra MPEP – 55 Selectra Amplatz 6 – 45 Selectra Slitter Tool Selectra Hook – 45 Selectra Extended Hook – 45 Selectra Amplatz 6 – 55 Selectra Multipurpose Hook – 55 Selectra BIO2 – 55 Selectra Right – 55 Selectra Right – 45 Selectra IC – 50 – 69 Selectra Hook – 55 Evia HF(-T) Enitra Enticos Sentus OTW QP L/S Corox LV-KIT Stratos Celerity Entovis HF(-T)

    Establishment Types

    Repack or Relabel Medical Device