Device Classification Name |
patch, pledget and intracardiac, petp, ptfe, polypropylene
|
510(k) Number |
K971726 |
Device Name |
CV PERI-GUARD - CARDIOVASCULAR PATCH |
Applicant |
BIO-VASCULAR, INC. |
2575 UNIVERSITY AVE. |
ST. PAUL,
MN
55114 -1024
|
|
Applicant Contact |
BARBARA ATZENHOEFER |
Correspondent |
BIO-VASCULAR, INC. |
2575 UNIVERSITY AVE. |
ST. PAUL,
MN
55114 -1024
|
|
Correspondent Contact |
BARBARA ATZENHOEFER |
Regulation Number | 870.3470
|
Classification Product Code |
|
Date Received | 05/09/1997 |
Decision Date | 04/10/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|