K162579 is an FDA 510(k) clearance for the VascuCel. This device is classified as a Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene (Class II - Special Controls, product code DXZ).
Submitted by Admedus Regen Pty, Ltd. (Malaga, AU). The FDA issued a Cleared decision on October 14, 2016, 29 days after receiving the submission on September 15, 2016.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3470.
| 510(k) Number | K162579 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 15, 2016 |
| Decision Date | October 14, 2016 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXZ - Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3470 |