The following data is part of a premarket notification filed by Acell, Inc. with the FDA for Matristem Ubm Pericardial Patch.
| Device ID | K191734 |
| 510k Number | K191734 |
| Device Name: | MatriStem UBM Pericardial Patch |
| Classification | Intracardiac Patch Or Pledget, Biologically Derived |
| Applicant | Acell, Inc. 6640 Eli Whitney Drive Suite 200 Columbia, MD 21046 |
| Contact | Michelle Huettner |
| Correspondent | Michelle Huettner Acell, Inc. 6640 Eli Whitney Drive Suite 200 Columbia, MD 21046 |
| Product Code | PSQ |
| CFR Regulation Number | 870.3470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-28 |
| Decision Date | 2019-11-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00386190002087 | K191734 | 000 |
| 00386190002070 | K191734 | 000 |
| 00386190002063 | K191734 | 000 |