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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Percutaneous Retrieval
510(k) Number K091563
Device Name RECRUIT MICROCATHETER
Applicant
Reverse Medical Corporation
13700 Alton Pkwy., Suite 167
Irvine,  CA  92618
Applicant Contact AMY ESKINA
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number870.5150
Classification Product Code
MMX  
Date Received05/28/2009
Decision Date 07/30/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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