Medical Device Manufacturer · US , Lake Oswego , OR

Biotronik, Inc. - FDA 510(k) Cleared Devices

85 submissions · 67 cleared · Since 1994

Recent clearances: BIOMONITOR IV (471155), Passeo-35 Xeo Peripheral Dilatation Catheter, Pantera Pro

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85

Total

67

Cleared

0

Denied

FDA 510(k) Regulatory Record - Biotronik, Inc. Cardiovascular ✕

85 devices

1-12 of 85

Cleared May 01, 2026

BIOMONITOR IV (471155)

Cardiovascular · 30d

Cleared Apr 04, 2025

Passeo-35 Xeo Peripheral Dilatation Catheter

Cardiovascular · 25d

Cleared Oct 25, 2024

Cardiovascular · 29d

Cleared CT Sep 12, 2024

Selectra 3D Lead Delivery System (443624-443629, 451789-451791)

Cardiovascular · 174d

Cleared Jul 11, 2024

Oscar Peripheral Multifunctional Catheter system

Cardiovascular · 27d

Cleared May 19, 2023

Cardiovascular · 95d

Cleared Feb 16, 2023

Passeo-35 Xeo Peripheral Dilatation Catheter

Cardiovascular · 218d

Cleared Jul 27, 2022

BIOMONITOR IIIm, BIOMONITOR III

Cardiovascular · 30d

Cleared Jul 19, 2022

Selectra Lead Implantation System

Cardiovascular · 8d

Cleared Jul 06, 2022

Oscar Peripheral Multifunctional Catheter system

Cardiovascular · 195d

Cleared Sep 02, 2021

MultiCath, AcQRate Dx Fixed Curve Catheter

Cardiovascular · 458d

Cleared Dec 08, 2020

Biomonitor III, Biomonitor IIIm

Cardiovascular · 155d

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