Medical Device Manufacturer · US , Lake Oswego , OR

Biotronik, Inc.

84 submissions · 66 cleared · Since 1994
84
Total
66
Cleared
0
Denied

Biotronik, Inc. — FDA 510(k) Submissions

Biotronik, Inc. has submitted 84 FDA 510(k) premarket notifications since 1994, of which 66 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Catheter, Percutaneous, Permanent Pacemaker Electrode, Recorder, Event, Implantable Cardiac, (with Arrhythmia Detection), Catheter, Angioplasty, Peripheral, Transluminal, Wire, Guide, Catheter . Use the specialty filter in the sidebar to narrow results.

84 devices
1–25 of 84
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
K250706 · LIT Catheter, Angioplasty,... · Cardiovascular
Apr 2025 25d
Pantera Pro; Pantera LEO
K242969 · LOX Catheters, Transluminal... · Cardiovascular
Oct 2024 29d
Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool (383119); Selectra Accessory Kit (375518)
K240787 · DQY Catheter, Percutaneous · Cardiovascular
Sep 2024 174d
Oscar Peripheral Multifunctional Catheter system
K241711 · LIT Catheter, Angioplasty,... · Cardiovascular
Jul 2024 27d
BIOMONITOR IV
K230375 · MXD Recorder, Event,... · Cardiovascular
May 2023 95d
Passeo-35 Xeo Peripheral Dilatation Catheter
K222065 · LIT Catheter, Angioplasty,... · Cardiovascular
Feb 2023 218d
BIOMONITOR IIIm, BIOMONITOR III
K221856 · MXD Recorder, Event,... · Cardiovascular
Jul 2022 30d
Selectra Lead Implantation System
K222037 · DQY Catheter, Percutaneous · Cardiovascular
Jul 2022 8d
Oscar Peripheral Multifunctional Catheter system
K214038 · LIT Catheter, Angioplasty,... · Cardiovascular
Jul 2022 195d
MultiCath, AcQRate Dx Fixed Curve Catheter
K201445 · DRF Catheter, Electrode... · Cardiovascular
Sep 2021 458d
Biomonitor III, Biomonitor IIIm
K201865 · MXD Recorder, Event,... · Cardiovascular
Dec 2020 155d
Selectra 3D Outer Guiding Catheters
K193474 · DQY Catheter, Percutaneous · Cardiovascular
Oct 2020 305d
Biomonitor III, Biomonitor IIIm
K200444 · MXD Recorder, Event,... · Cardiovascular
Apr 2020 59d
Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool
K192996 · DQY Catheter, Percutaneous · Cardiovascular
Nov 2019 24d
Biotronik Stylets
K191469 · DRB Stylet, Catheter · Cardiovascular
Aug 2019 59d
BIOMONITOR III, Remote Assistant III
K190548 · MXD Recorder, Event,... · Cardiovascular
Jul 2019 122d
Selectra Catheters, Selectra Accessory Kit
K183265 · DQY Catheter, Percutaneous · Cardiovascular
Dec 2018 20d
BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, Set
K171514 · MXD Recorder, Event,... · Cardiovascular
Jun 2017 36d
BioMonitor 2-AF, BioMonitor 2-S
K170628 · MXD Recorder, Event,... · Cardiovascular
Mar 2017 29d
Pantera LEO
K163660 · LOX Catheters, Transluminal... · Cardiovascular
Jan 2017 30d
Pantera Pro
K160985 · LOX Catheters, Transluminal... · Cardiovascular
Oct 2016 182d
BioMonitor 2-AF, BioMonitor 2-S
K152995 · MXD Recorder, Event,... · Cardiovascular
Apr 2016 181d
Passeo-18 Peripheral Dilation Catheter
K151744 · LIT Catheter, Angioplasty,... · Cardiovascular
Oct 2015 101d
Passeo-14 Peripheral Dilatation Catheter
K152240 · LIT Catheter, Angioplasty,... · Cardiovascular
Oct 2015 59d
Selectra Catheters and Selectra Accessory Kit
K151409 · DQY Catheter, Percutaneous · Cardiovascular
Aug 2015 73d

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