K200566 is an FDA 510(k) clearance for the ADAPT Tissue. This device is classified as a Intracardiac Patch Or Pledget, Biologically Derived (Class II - Special Controls, product code PSQ).
Submitted by Admedus Regen Pty, Ltd. (Malaga, AU). The FDA issued a Cleared decision on April 3, 2020, 30 days after receiving the submission on March 4, 2020.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3470. To Repair Defects, To Be Used For Patch Grafting, To Repair Tissue, And To Buttress Sutures In The Heart And Vasculature..
| 510(k) Number | K200566 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 04, 2020 |
| Decision Date | April 03, 2020 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | PSQ - Intracardiac Patch Or Pledget, Biologically Derived |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3470 |
| Definition | To Repair Defects, To Be Used For Patch Grafting, To Repair Tissue, And To Buttress Sutures In The Heart And Vasculature. |