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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Ultrasound, Intravascular
510(k) Number K200410
Device Name Reconnaissance PV .018 OTW Digital IVUS Catheter
Applicant
Philips Image Guided Therapy Corporation
3721 Valley Centre Dr., Suite 500
San Diego,  CA  92130
Applicant Contact Mary Stanners
Correspondent
Philips Image Guided Therapy Corporation
3721 Valley Centre Dr., Suite 500
San Diego,  CA  92130
Correspondent Contact Mary Stanners
Regulation Number870.1200
Classification Product Code
OBJ  
Subsequent Product Code
ITX  
Date Received02/19/2020
Decision Date 05/22/2020
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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