FDA 510(k) Application Details - K213494

Device Classification Name Device, Percutaneous Retrieval

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510(K) Number K213494
Device Name Device, Percutaneous Retrieval
Applicant Abbott Medical
15900 Valley View Court
Sylmar, CA 91342 US
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Contact Bijal Jain
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Regulation Number 870.5150

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Classification Product Code MMX
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Date Received 11/01/2021
Decision Date 04/01/2022
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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