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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 K152498
Device Name SoloPath Re-Collapsible Access System
Applicant
ONSET MEDICAL CORPORATION
13900 ALTON PARKWAY, SUITE 120
IRVINE,  CA  92618
Applicant Contact Monika McDole-Russell
Correspondent
TERUMO Corporation
265 Davidson Ave, Suite 320
Somerset,  NJ  08873
Correspondent Contact Monika McDole-Russell
Regulation Number870.1340
Classification Product Code
DYB  
Date Received09/01/2015
Decision Date 01/05/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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