FDA 510(k) Application Details - K222873

Device Classification Name Catheter, Percutaneous

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510(K) Number K222873
Device Name Catheter, Percutaneous
Applicant Medtronic
8200 Coral Sea Street NE
Mounds View, MN 55112 US
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Contact Sarah Meyer
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Regulation Number 870.1250

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Classification Product Code DQY
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Date Received 09/22/2022
Decision Date 11/07/2022
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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