K171620 is an FDA 510(k) clearance for the PiCCO Catheter. This device is classified as a Probe, Thermodilution (Class II - Special Controls, product code KRB).
Submitted by Pulsion Medical Systems SE (Feldkirchen, DE). The FDA issued a Cleared decision on February 21, 2018, 264 days after receiving the submission on June 2, 2017.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1915.
| 510(k) Number | K171620 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 02, 2017 |
| Decision Date | February 21, 2018 |
| Days to Decision | 264 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | KRB - Probe, Thermodilution |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1915 |