Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1028232

FEI Number

1028232

Entity Name

BIOTRONIK, INC.

City/State/Country

LAKE OSWEGO, OR, US

Establishment Address

6024 JEAN RD., LAKE OSWEGO, OR 97035, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

BIOTRONIK, INC. (Owner Number: 1028232)

Owner / Operator Contact Address

6024 JEAN RD., --, Lake Oswego, OR 97035, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K193474

PMA Number

N/A

All Registered 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 S 60 PK-175 BS IS-1 Blind Plug Eluna PK-83 Etrinsa EFH 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 Renamic NEO 2301.U Model 3175 PSW 2301.U Dextrus Reliaty Reocor HMSC Version 3.64.1 HMSC 3.55 ICS 3000 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 S 60 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

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
DTD	Pacemaker Lead Adaptor	Cardiovascular	Class 2	870.3620	2008-05-21
DTE	Pulse-Generator, Pacemaker, External	Cardiovascular	Class 2	870.3600	2006-04-11
DTA	Tester, Pacemaker Electrode Function	Cardiovascular	Class 2	870.3720	2006-04-11
NVY	Permanent Defibrillator Electrodes	Unknown	Class 3	N/A	2006-04-11
KRG	Programmer, Pacemaker	Cardiovascular	Class 3	870.3700	2006-04-11
LWS	Implantable Cardioverter Defibrillator (Non-Crt)	Unknown	Class 3	N/A	2006-04-11
DTB	Permanent Pacemaker Electrode	Cardiovascular	Class 3	870.3680	2008-05-21
LWP	Implantable Pulse Generator, Pacemaker (Non-Crt)	Unknown	Class 3	N/A	2008-05-21
NIK	Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)	Unknown	Class 3	N/A	2008-05-21
LWS	Implantable Cardioverter Defibrillator (Non-Crt)	Unknown	Class 3	N/A	2008-05-21
NVZ	Pulse Generator, Permanent, Implantable	Unknown	Class 3	N/A	2008-05-21
NKE	Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)	Unknown	Class 3	N/A	2008-05-21
DXY	Implantable Pacemaker Pulse-Generator	Cardiovascular	Class 3	870.3610	2008-05-21
OSR	Pacemaker/Icd/Crt Non-Implanted Components	Unknown	Class 3	N/A	2008-05-21
NVN	Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes	Unknown	Class 3	N/A	2008-05-21
OVJ	Pulse Generator, External Pacemaker, Dual Chamber	Cardiovascular	Class 2	870.3600	2008-05-21
KRG	Programmer, Pacemaker	Cardiovascular	Class 3	870.3700	2008-05-21
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2022-07-18
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2025-04-08
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	Class 2	870.5100	2025-04-08
DTD	Pacemaker Lead Adaptor	Cardiovascular	Class 2	870.3620	2014-06-24
DRB	Stylet, Catheter	Cardiovascular	Class 2	870.1380	2019-08-07
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2021-10-18
MXD	Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)	Cardiovascular	Class 2	870.1025	2020-04-23
KRG	Programmer, Pacemaker	Cardiovascular	Class 3	870.3700	2014-06-24
LWP	Implantable Pulse Generator, Pacemaker (Non-Crt)	Unknown	Class 3	N/A	2014-06-24
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2022-07-18
DTE	Pulse-Generator, Pacemaker, External	Cardiovascular	Class 2	870.3600	2008-05-21
MXD	Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)	Cardiovascular	Class 2	870.1025	2015-03-23
MXD	Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)	Cardiovascular	Class 2	870.1025	2023-05-22
DTD	Pacemaker Lead Adaptor	Cardiovascular	Class 2	870.3620	2014-06-24
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2020-11-10

Official Correspondent

JON BRUMBAUGH

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BIOTRONIK, INC.

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 1028232. Last updated year: 2026. Please use registration number 1028232 when referencing this establishment in official correspondence.