Medical Device Manufacturer · US , Westbrook , CT

Pulsion Medical Systems SE - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2012

Recent clearances: PulsioFlex Monitoring System with ProAQT Sensor, PiCCO Catheter, PulsioFlex Monitoring System

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4
Total
4
Cleared
0
Denied

FDA 510(k) Regulatory Record - Pulsion Medical Systems SE Cardiovascular ✕

4 devices
1-4 of 4
Cleared Apr 30, 2020
PulsioFlex Monitoring System with ProAQT Sensor
K192169 · DXG
Cardiovascular · 265d
Cleared Feb 21, 2018
PiCCO Catheter
K171620 · KRB
Cardiovascular · 264d
Cleared Jan 18, 2018
PulsioFlex Monitoring System
K172259 · DXG
Cardiovascular · 175d
Cleared Aug 02, 2012
PULSIOFLEX MONITORING SYSTEM WITH PICCO MODULE
K122121 · DXG
Cardiovascular · 16d
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