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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reprocessed Intravascular Ultrasound Catheter
510(k) Number K092425
Device Name REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETERS, MODEL SNDSTR10
Applicant
Ascent Healthcare Solutions
10232 S. 51st St.
Phoenix,  AZ  85044
Applicant Contact AMANDA BABCOCK
Correspondent
Ascent Healthcare Solutions
10232 S. 51st St.
Phoenix,  AZ  85044
Correspondent Contact AMANDA BABCOCK
Regulation Number870.1200
Classification Product Code
OWQ  
Date Received08/07/2009
Decision Date 10/21/2009
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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