The following data is part of a premarket notification filed by Meadox Medicals, Div. Boston Scientific Corp. with the FDA for Hemashield Finesse Ultra-thin, Knitted Cardiovascular Patch.
| Device ID | K962342 |
| 510k Number | K962342 |
| Device Name: | HEMASHIELD FINESSE ULTRA-THIN, KNITTED CARDIOVASCULAR PATCH |
| Classification | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene |
| Applicant | MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. 112 BAUER DR. Oakland, NJ 07436 |
| Contact | Susan Eichler-huston |
| Correspondent | Susan Eichler-huston 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 | 1996-06-18 |
| Decision Date | 1996-09-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00384401017981 | K962342 | 000 |
| 00384401017974 | K962342 | 000 |
| 00384401017967 | K962342 | 000 |
| 00384401017950 | K962342 | 000 |
| 00384401017943 | K962342 | 000 |