Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9610139

FEI Number

3002806500

Entity Name

BIOTRONIK SE & CO. KG

City/State/Country

BERLIN, DE

Establishment Address

WOERMANNKEHRE 1, BERLIN D-12359, DE

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Repack or Relabel Medical Device,Manufacture Medical Device

Owner / Operator

BIOTRONIK SE & CO. KG (Owner Number: 9018331)

Owner / Operator Contact Address

6024 Jean Road, Lake Oswego, OR 97035, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K143503

PMA Number

N/A

All Registered Proprietary Names

Selectra IC Resilience Percutaneous Lead Prospera Spinal Cord Stimulation (SCS) System HomeStream Remote Management TrueLock Embrace One S 60-S S 60-J S 60-K S 53-K S 45-S S 45-J S 53-J S 45-K S 53-JL S 60-F S 65-A S 45-F S 65-E S 85-G OTW S 45-JL S 85-K OTW S 53-F S 75-K S 60-C S 65-C S 65-K S 75-G OTW S 75-K OTW S 53-S S 75-C A1-CS-SB Selectra Accessory Kit MPK-4-R MPK-10-R BIOTRONIK test magnet BioMonitor 2-AF BioMonitor 2-S FIT - Fast Insert Tool 1 + 2, Set Remote Assistant MPK-10-R MPK-4-R Patient App Version 2.9 BIOMONITOR III BIOMONITOR IIIm Selectra slitter tool Selectra Selectra IC 90 69 Selectra Hook 55 Selectra 3D-40-39 Selectra Extended Hook 55 Selectra Amplatz 6 45 Selectra Multipurpose Hook 45 Selectra Straight 55 Selectra Accessory Kit Selectra IC 50 59 Selectra 3D-55-32 Selectra 3D-55-42 Selectra Extended Hook 45 Selectra Right 55 Selectra Amplatz 6 55 Selectra Slitter Tool Selectra 3D-40-42 Selectra MPEP 55 Selectra IC 90 59 Selectra MPEP 45 Selectra Right 45 Selectra Straight 45 Selectra BIO2 45 Selectra BIO2 55 Selectra 3D-65-32 Selectra 3D-40-32 Selectra 3D-65-39 Selectra Multipurpose Hook 55 Selectra IC 50 69 Selectra 3D-65-42 Selectra Hook 45 Selectra 3D-55-39 BK-IS BK-A BK-B Model 6653 EDP Model 3150 Renamic P-KIT Estella Model 3145 Dextrus Reliaty Reocor Model 6652 Model 3171 Setrox S Effecta Model 6646 Evia ICS 3000 Selox Model 3175 Tilda Solia T 53 Solia S 60 Solia CSP S 53 Solia JT 45 Solia CSP S 60 Solia S 45 Solia S 53 Solia T 60 Solia JT 53 Selectra VisionWire Selectra 3D-65-39 Selectra 3D-40-32 Selectra 3D-40-39 Selectra 3D-55-32 Selectra 3D-55-39 Selectra 3D-55-42 Selectra 3D-65-32 Selectra 3D-40-42 PSW 1503.U PSW 1502.U Etrinsa HF-T Eluna HF-T Edora Evity Enitra Sentus OTW QP L/S Stratos Renamic CardioMessenger Corox ICS 3000 Celerity LV-KIT Evia HF(-T) Home Monitoring Iforia Iperia Itrevia PSW 1502.U Inventra PSW 1507.U PSW 1503.U PSW 1506.U BS IS4 Ilivia Intica Acticor family CardioMessenger Smart 4G ICS 3000 Renamic CardioMessenger Acticor Sky Lumax Home Monitoring Ilesto S 60-K S 60-J S 60-S Selectra Lead Introducer System Patient App Version 2.2 BIOMONITOR III BIOMONITOR IIIm Patient App 2.5 Patient App 2.4.1 Patient App 2.7 Biomonitor

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2015-08-10
LGW	Stimulator, Spinal-Cord, Totally Implanted For Pain Relief	Unknown	Class 3	N/A	2023-04-04
DRB	Stylet, Catheter	Cardiovascular	Class 2	870.1380	2019-08-07
DTD	Pacemaker Lead Adaptor	Cardiovascular	Class 2	870.3620	2014-06-23
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2012-11-12
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2012-11-12
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2022-08-05
DTG	Magnet, Test, Pacemaker	Cardiovascular	Class 1	870.3690	2012-11-15
MXD	Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)	Cardiovascular	Class 2	870.1025	2016-04-22
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2021-10-20
MXD	Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)	Cardiovascular	Class 2	870.1025	2025-02-10
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2012-11-12
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2012-11-12
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2024-09-16
DTD	Pacemaker Lead Adaptor	Cardiovascular	Class 2	870.3620	2014-06-23
NVZ	Pulse Generator, Permanent, Implantable	Unknown	Class 3	N/A	2007-10-31
NKE	Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)	Unknown	Class 3	N/A	2007-10-31
DTB	Permanent Pacemaker Electrode	Cardiovascular	Class 3	870.3680	2007-10-31
LWS	Implantable Cardioverter Defibrillator (Non-Crt)	Unknown	Class 3	N/A	2007-10-31
OSR	Pacemaker/Icd/Crt Non-Implanted Components	Unknown	Class 3	N/A	2007-10-31
OVJ	Pulse Generator, External Pacemaker, Dual Chamber	Cardiovascular	Class 2	870.3600	2007-10-31
NIK	Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)	Unknown	Class 3	N/A	2007-10-31
KRG	Programmer, Pacemaker	Cardiovascular	Class 3	870.3700	2007-10-31
DXY	Implantable Pacemaker Pulse-Generator	Cardiovascular	Class 3	870.3610	2007-10-31
NVN	Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes	Unknown	Class 3	N/A	2007-10-31
LWP	Implantable Pulse Generator, Pacemaker (Non-Crt)	Unknown	Class 3	N/A	2007-10-31
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2012-11-12
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2012-11-12
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2016-01-27
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2020-11-10
NKE	Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)	Unknown	Class 3	N/A	2008-05-22
NIK	Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)	Unknown	Class 3	N/A	2008-05-22
OJX	Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode	Unknown	Class 3	N/A	2008-05-22
NVZ	Pulse Generator, Permanent, Implantable	Unknown	Class 3	N/A	2008-05-22
LWS	Implantable Cardioverter Defibrillator (Non-Crt)	Unknown	Class 3	N/A	2008-05-22
LWS	Implantable Cardioverter Defibrillator (Non-Crt)	Unknown	Class 3	N/A	2008-12-30
NVZ	Pulse Generator, Permanent, Implantable	Unknown	Class 3	N/A	2008-12-30
NKE	Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)	Unknown	Class 3	N/A	2008-12-30
OJX	Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode	Unknown	Class 3	N/A	2008-12-30
NIK	Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)	Unknown	Class 3	N/A	2008-12-30
MRM	Defibrillator, Implantable, Dual-Chamber	Unknown	Class 3	N/A	2008-12-30
OSR	Pacemaker/Icd/Crt Non-Implanted Components	Unknown	Class 3	N/A	2008-12-30
LWP	Implantable Pulse Generator, Pacemaker (Non-Crt)	Unknown	Class 3	N/A	2014-06-23
KRG	Programmer, Pacemaker	Cardiovascular	Class 3	870.3700	2014-06-23
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2022-07-20
MXD	Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)	Cardiovascular	Class 2	870.1025	2020-04-23
MXD	Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)	Cardiovascular	Class 2	870.1025	2015-03-23

Official Correspondent

No official correspondent registered.

US Agent Details

Jon Brumbaugh Business: BIOTRONIK, Inc. Email: jon.brumbaugh@biotronik.com Phone: (503) 9707014

Related Public Records

Same Entity

BIOTRONIK SE & CO. KG

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K043580	Chestnut Medical Technologies, Inc.	ALLIGATOR RETRIEVAL DEVICE (ARD)	2005-03-24
K982883	Medtronics Interventional Vascular	MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETER	1998-09-04
K132420	Reflow Medical	WINGMAN EXTENDABLE TIP SUPPORT CATHETER	2013-09-19
K082339	Endocross, Ltd.	ENABLER-P SUPPORT CATHETER	2008-11-20
K210009	CenterPoint Systems, LLC	Guiding Catheter	2021-11-24

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2010	Penumbra Inc.	2	Penumbra Neuron Delivery Catheter 070, percutaneous catheter, catalog numbers PND6F0701058, PND6F070956, PND6F0701058M, and PND6F070956M; manufactured by Penumbra, Inc., Alameda, CA. Indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
Z-0003-2014	Cordis Corporation	2	Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.
Z-0009-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter
Z-0010-04	Bard Peripheral Vascular	2	Conquest Balloon Dilation Catheters Model/Catalog Number CQ 75124
Z-0010-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430, cardiac guide catheter

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9610139. Last updated year: 2026. Please use registration number 9610139 when referencing this establishment in official correspondence.