K190049 is an FDA 510(k) clearance for the Sim&Size. This device is classified as a Software For Visualization Of Vascular Anatomy And Intravascular Devices (Class II - Special Controls, product code PZO).
Submitted by Sim&Cure (Grabels, FR). The FDA issued a Cleared decision on September 17, 2019, 250 days after receiving the submission on January 10, 2019.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 892.2050. Visualization And Measurement Of Blood Vessels And Intravascular Devices For Preoperational Planning..
| 510(k) Number | K190049 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 10, 2019 |
| Decision Date | September 17, 2019 |
| Days to Decision | 250 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | PZO - Software For Visualization Of Vascular Anatomy And Intravascular Devices |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.2050 |
| Definition | Visualization And Measurement Of Blood Vessels And Intravascular Devices For Preoperational Planning. |