The following data is part of a premarket notification filed by Lifenet Health with the FDA for Matracell Decellularized Pulmonary Artery Patch Allograft.
| Device ID | K081438 |
| 510k Number | K081438 |
| Device Name: | MATRACELL DECELLULARIZED PULMONARY ARTERY PATCH ALLOGRAFT |
| Classification | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene |
| Applicant | LifeNet Health 1864 CONCERT DR. Virginia Beach, VA 23453 |
| Contact | Alyce Linthurst Jones |
| Correspondent | Alyce Linthurst Jones LifeNet Health 1864 CONCERT DR. Virginia Beach, VA 23453 |
| Product Code | DXZ |
| CFR Regulation Number | 870.3470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-22 |
| Decision Date | 2008-10-17 |
| Summary: | summary |