K100739 is an FDA 510(k) clearance for the VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5. This device is classified as a Probe, Thermodilution (Class II - Special Controls, product code KRB).
Submitted by Edwards Lifesciences, LLC (Irvine, US). The FDA issued a Cleared decision on December 7, 2010, 266 days after receiving the submission on March 16, 2010.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1915.
| 510(k) Number | K100739 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 16, 2010 |
| Decision Date | December 07, 2010 |
| Days to Decision | 266 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 |