FDA 510(k) Application Details - K241370

Device Classification Name Introducer, Catheter

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510(K) Number K241370
Device Name Introducer, Catheter
Applicant Abbott Medical
14901 DeVeau Place
Minnetonka, MN 55345 US
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Contact Alyssa Timmers
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Regulation Number 870.1340

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Classification Product Code DYB
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Date Received 05/14/2024
Decision Date 06/13/2024
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

FDA Source Information for K241370


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