Medical Device Manufacturer · US , Concord , MA

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

5 submissions · 5 cleared · Since 2002

Recent clearances: PULSION PICCO2 (8500), CEVOX OPTICAL MODULE (PC3015), CEVOX DISPOSABLE PROBES (PV2022-30 THRU -38, PV2022-46 THRU -48), PULSION PICCO-2, MODEL 8500, PULSION PULSIOCATH THERMODILUTION CATHETERS & ACCESSORIES

View 5 510(k) Devices ↓ Official Website

5

Total

5

Cleared

0

Denied

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

5 devices

1-5 of 5

Cleared Jun 18, 2010

PULSION PICCO2 (8500), CEVOX OPTICAL MODULE (PC3015), CEVOX DISPOSABLE...

Cardiovascular · 366d

Cleared Oct 18, 2007

PULSION PICCO-2, MODEL 8500

Cardiovascular · 21d

Cleared Sep 19, 2007

PULSION PULSIOCATH THERMODILUTION CATHETERS & ACCESSORIES

Cardiovascular · 28d

Cleared Jul 25, 2006

PULSION PICCO PLUS, MODEL 8100

Cardiovascular · 113d

Cleared May 23, 2002

PULSION PULSIOCATH PICCO MONITORING KIT, INJECTATE SENSOR TEMPERATURE HOUSING...

Cardiovascular · 90d