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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Introducer, Catheter
510(k) Number K242169
Device Name Morph DNA Steerable Introducer Sheath
Applicant
Biocardia
320 Soquel Way
Sunnyvale,  CA  94085
Applicant Contact Ed Gillis
Correspondent
Biocardia
320 Soquel Way
Sunnyvale,  CA  94085
Correspondent Contact Peter Altman
Regulation Number870.1340
Classification Product Code
DYB  
Date Received07/24/2024
Decision Date 08/23/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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