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FDA 510(k) Application Details - K221628
Device Classification Name
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
More FDA Info for this Device
510(K) Number
K221628
Device Name
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Applicant
PECA Labs
4424 Penn Ave, Suite 201
Pittsburgh, PA 15224 US
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Contact
Doug Bernstein
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Regulation Number
870.3450
More FDA Info for this Regulation Number
Classification Product Code
DSY
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More FDA Info for this Product Code
Date Received
06/06/2022
Decision Date
08/04/2022
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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