Device Classification Name |
intracardiac patch or pledget, biologically derived
|
510(k) Number |
K221029 |
Device Name |
PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch |
Applicant |
Synovis Life Technologies, Inc. |
(A Subsidiary of Baxter International Inc.) |
2575 University Avenue West |
St. Paul,
MN
55114
|
|
Applicant Contact |
Megan Sajjad |
Correspondent |
Synovis Life Technologies, Inc. |
(A Subsidiary of Baxter International Inc.) |
2575 University Avenue West |
St. Paul,
MN
55114
|
|
Correspondent Contact |
Megan Sajjad |
Regulation Number | 870.3470
|
Classification Product Code |
|
Date Received | 04/07/2022 |
Decision Date | 10/19/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|