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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 K100819
Device Name THE SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER
Applicant
Onset Medical Corporation
13900 Alton Pkwy. Suite 120
Irvine,  CA  92618
Applicant Contact JOSEPH BISHOP
Correspondent
Onset Medical Corporation
13900 Alton Pkwy. Suite 120
Irvine,  CA  92618
Correspondent Contact JOSEPH BISHOP
Regulation Number870.1340
Classification Product Code
DYB  
Date Received03/23/2010
Decision Date 08/02/2010
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
Recalls CDRH Recalls
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