The following data is part of a premarket notification filed by Macropore Biosurgery, Inc. with the FDA for Macropore Cardio-wrap (ts).
| Device ID | K031785 |
| 510k Number | K031785 |
| Device Name: | MACROPORE CARDIO-WRAP (TS) |
| Classification | Pericardial Patch To Facilitate Revision Surgeries |
| Applicant | MACROPORE BIOSURGERY, INC. 6740 TOP GUN ST. San Diego, CA 92121 |
| Contact | Kenneth K Kleinhenz |
| Correspondent | Kenneth K Kleinhenz MACROPORE BIOSURGERY, INC. 6740 TOP GUN ST. San Diego, CA 92121 |
| Product Code | OMH |
| CFR Regulation Number | 870.3470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-10 |
| Decision Date | 2003-09-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18964050365047 | K031785 | 000 |
| 18964050365023 | K031785 | 000 |
| 18964050362046 | K031785 | 000 |
| 18964050362022 | K031785 | 000 |
| 00810057380266 | K031785 | 000 |
| 00810057380259 | K031785 | 000 |