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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Assisted Reproduction
510(k) Number K162064
Device Name CrossBay IVF Embryo Transfer Catheter Set
Applicant
Crossbay Medical, Inc.
13240 Evening Creek Dr., Suite 304
San Diego,  CA  92128
Applicant Contact Piush Vidyarthi
Correspondent
Domecus Consulting Services, LLC
1171 Barroihet Dr.
Hillsborough,  CA  94010
Correspondent Contact Cindy Domecus
Regulation Number884.6110
Classification Product Code
MQF  
Date Received07/26/2016
Decision Date 01/05/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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