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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter For Crossing Total Occlusions
510(k) Number K092175
Device Name THE CROSSER S6 CATHETER, THE CROSSER SYSTEM ELECTRONICS, MODEL CRUS6, GEN200
Applicant
Flowcardia, Inc.
745 N. Pastoria Ave.
Sunnyvale,  CA  94085
Applicant Contact Dustin Michaels
Correspondent
Flowcardia, Inc.
745 N. Pastoria Ave.
Sunnyvale,  CA  94085
Correspondent Contact Dustin Michaels
Regulation Number870.1250
Classification Product Code
PDU  
Date Received07/21/2009
Decision Date 02/17/2010
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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