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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K130378
Device Name RESPIGUIDE DELIVERY SYSTEM
Applicant
Respicardia
12400 Whitewater Dr.
Suite 150
Minnetonka,  MN  55343
Applicant Contact BONNIE LABOSKY
Correspondent
Respicardia
12400 Whitewater Dr.
Suite 150
Minnetonka,  MN  55343
Correspondent Contact BONNIE LABOSKY
Regulation Number870.1250
Classification Product Code
DQY  
Subsequent Product Code
DQO  
Date Received02/14/2013
Decision Date 10/17/2013
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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