Pulsion Medical Systems AG
Cornelius, NC, US
Pulsion Medical Systems AG appears in FDA device records in Cornelius, NC. FDA records list 8 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 8
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 8 510(k) clearances for Pulsion Medical Systems AG between 2000 and 2011. The busiest year on record is 2000, with 2. The most recent is 2011, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2000 | 2 |
| 2002 | 1 |
| 2006 | 1 |
| 2007 | 2 |
| 2010 | 1 |
| 2011 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K112448 | PULSIOFLEX | DXG | Substantially Equivalent | |
| K091786 | PULSION PICCO2 (8500), CEVOX OPTICAL MODULE (PC3015), CEVOX DISPOSABLE PROBES (PV2022-30 THRU -38, PV2022-46 THRU -48) | DXG | Substantially Equivalent | |
| K072735 | PULSION PICCO-2, MODEL 8500 | DXG | Substantially Equivalent | |
| K072364 | PULSION PULSIOCATH THERMODILUTION CATHETERS & ACCESSORIES | KRB | Substantially Equivalent | |
| K060898 | PULSION PICCO PLUS, MODEL 8100 | DXG | Substantially Equivalent | |
| K020587 | PULSION PULSIOCATH PICCO MONITORING KIT, INJECTATE SENSOR TEMPERATURE HOUSING PV 4046 | KRB | Substantially Equivalent | |
| K001762 | PULSION CONTINUOUS PULSE CONTOUR CARDIAC OUTPUT (PICCO) SYSTEM | DXG | Substantially Equivalent | |
| K991886 | PULSION PULSIOCATH, PULSION PCCO MONITORING KIT, PULSION IN-LINE INJECTATE SENSOR | KRB | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain