The following data is part of a premarket notification filed by Meadox Medicals, Div. Boston Scientific Corp. with the FDA for Hemashield Knitted Double Velour Cardiovascular Fabric.
| Device ID | K955349 |
| 510k Number | K955349 |
| Device Name: | HEMASHIELD KNITTED DOUBLE VELOUR CARDIOVASCULAR FABRIC |
| Classification | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene |
| Applicant | MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. 112 BAUER DR. Oakland, NJ 07436 |
| Contact | Carolyn Tauber |
| Correspondent | Carolyn Tauber MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. 112 BAUER DR. Oakland, NJ 07436 |
| Product Code | DXZ |
| CFR Regulation Number | 870.3470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-21 |
| Decision Date | 1996-02-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00384401018827 | K955349 | 000 |
| 00384401017868 | K955349 | 000 |
| 00384401017875 | K955349 | 000 |
| 00384401017882 | K955349 | 000 |
| 00384401017899 | K955349 | 000 |
| 00384401017905 | K955349 | 000 |
| 00384401017912 | K955349 | 000 |
| 00384401017929 | K955349 | 000 |
| 00384401017936 | K955349 | 000 |
| 00384401018803 | K955349 | 000 |
| 00384401018810 | K955349 | 000 |
| 00384401017851 | K955349 | 000 |