Medical Device Manufacturer · US , Concord , MA

Pulsion Medical Systems AG

5 submissions · 5 cleared · Since 2002

Total

Cleared

Denied

Pulsion Medical Systems AG — FDA 510(k) Submissions

Pulsion Medical Systems AG has submitted 5 FDA 510(k) premarket notifications since 2002, of which 5 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Computer, Diagnostic, Pre-programmed, Single-function, Probe, Thermodilution . Use the specialty filter in the sidebar to narrow results.

5 devices

1–5 of 5

PULSION PICCO2 (8500), CEVOX OPTICAL MODULE (PC3015), CEVOX DISPOSABLE PROBES (PV2022-30 THRU -38, PV2022-46 THRU -48)

K091786 · DXG Computer, Diagnostic,... · Cardiovascular

Jun 2010 366d

PULSION PICCO-2, MODEL 8500

K072735 · DXG Computer, Diagnostic,... · Cardiovascular

Oct 2007 21d

PULSION PULSIOCATH THERMODILUTION CATHETERS & ACCESSORIES

K072364 · KRB Probe, Thermodilution · Cardiovascular

Sep 2007 28d

PULSION PICCO PLUS, MODEL 8100