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FDA 510(k) Application Details - K221032
Device Classification Name
More FDA Info for this Device
510(K) Number
K221032
Device Name
Vascu-Guard Vascular Repair Patch
Applicant
Synovis Life Technologies, Inc.
(A Subsidiary of Baxter International Inc.)
2575 University Avenue West
St. Paul, MN 55114 US
Other 510(k) Applications for this Company
Contact
Sajjad Megan
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PSQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/07/2022
Decision Date
10/19/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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