Device Classification Name |
patch, pledget and intracardiac, petp, ptfe, polypropylene
|
510(k) Number |
K983602 |
Device Name |
CV PERI-GUARD AND VASCU-GUARD |
Applicant |
BIO-VASCULAR, INC. |
2575 UNIVERSITY AVE. |
ST. PAUL,
MN
55114 -1024
|
|
Applicant Contact |
DIANNA L GECK |
Correspondent |
BIO-VASCULAR, INC. |
2575 UNIVERSITY AVE. |
ST. PAUL,
MN
55114 -1024
|
|
Correspondent Contact |
DIANNA L GECK |
Regulation Number | 870.3470
|
Classification Product Code |
|
Date Received | 10/13/1998 |
Decision Date | 11/12/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|