FDA 510(k) Application Details - K230248

Device Classification Name Clamp, Vascular

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510(K) Number K230248
Device Name Clamp, Vascular
Applicant Vascular Graft Solutions, Ltd.
24 Raoul Wallenberg Street
Tel-Aviv 6971921 IL
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Contact Orit Yarden
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Regulation Number 870.4450

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Classification Product Code DXC
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Date Received 01/30/2023
Decision Date 02/28/2023
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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