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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K181563
Device Name The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology
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 Number870.1250
Classification Product Code
DQY  
Subsequent Product Code
DYB  
Date Received06/14/2018
Decision Date 09/26/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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