The following data is part of a premarket notification filed by Admedus Regen Pty Ltd with the FDA for Cardiocel 3d.
| Device ID | K170951 |
| 510k Number | K170951 |
| Device Name: | CardioCel 3D |
| Classification | Intracardiac Patch Or Pledget, Biologically Derived |
| Applicant | Admedus Regen Pty Ltd 26 Harris Road Malaga, AU 6090 |
| Contact | Mary E. Donlin |
| Correspondent | Mary E. Donlin Admedus Corporation 860 Blue Gentian Road Ste 295 Eagan, MN 55121 |
| Product Code | PSQ |
| CFR Regulation Number | 870.3470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-31 |
| Decision Date | 2017-04-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09348992000549 | K170951 | 000 |
| 09348992000655 | K170951 | 000 |
| 09348992000648 | K170951 | 000 |
| 09348992000358 | K170951 | 000 |
| 09348992000341 | K170951 | 000 |
| 09348992000334 | K170951 | 000 |
| 09348992000327 | K170951 | 000 |
| 09348992000280 | K170951 | 000 |