The following data is part of a premarket notification filed by Pulsion Medical Systems Se with the FDA for Picco Catheter.
| Device ID | K171620 |
| 510k Number | K171620 |
| Device Name: | PiCCO Catheter |
| Classification | Probe, Thermodilution |
| Applicant | PULSION Medical Systems SE Hans-Riedl-Strasse 17 Feldkirchen, DE 85622 |
| Contact | Ingrid Rohm |
| Correspondent | Mark Dinger Getinge 45 Barbour Pond Drive Wayne, NJ 07470 |
| Product Code | KRB |
| CFR Regulation Number | 870.1915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-02 |
| Decision Date | 2018-02-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 24250094500973 | K171620 | 000 |
| 07325710017043 | K171620 | 000 |
| 07325710017067 | K171620 | 000 |
| 07325710017098 | K171620 | 000 |
| 07325710017104 | K171620 | 000 |
| 04250094500931 | K171620 | 000 |
| 24250094500942 | K171620 | 000 |
| 24250094500959 | K171620 | 000 |
| 24250094500966 | K171620 | 000 |
| 07325710011607 | K171620 | 000 |