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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 K182243
Device Name The CVC WAND Safety Introducer with Valved Peelable Sheath
Applicant
Access Scientific, LLC
3910 Sorrento Valley Blvd., Suite 200
San Diego,  CA  92121
Applicant Contact Martina Nguyen
Correspondent
Access Scientific, LLC
3910 Sorrento Valley Blvd., Suite 200
San Diego,  CA  92121
Correspondent Contact Martina Nguyen
Regulation Number870.1340
Classification Product Code
DYB  
Date Received08/20/2018
Decision Date 09/18/2018
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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