FDA 510(k) Application Details - K222083

Device Classification Name Device, Percutaneous Retrieval

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510(K) Number K222083
Device Name Device, Percutaneous Retrieval
Applicant LimFlow Inc.
3031 Tisch Way - 110 Plaza West
San Jose, CA 95128 US
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Contact Zachary Woodson
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Regulation Number 870.5150

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Classification Product Code MMX
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Date Received 07/15/2022
Decision Date 08/09/2022
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 Y
Expedited Review



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