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 |