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FDA 510(k) Application Details - K202703
Device Classification Name
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
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510(K) Number
K202703
Device Name
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Applicant
Vascutek Ltd
Newmains Avenue
Inchinnan PA4 9RR GB
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Contact
Chirag Merchant
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Regulation Number
870.3450
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Classification Product Code
DSY
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More FDA Info for this Product Code
Date Received
09/16/2020
Decision Date
04/06/2021
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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