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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
510(k) Number K891576
Device Name FEM-FLEX FEMORAL ACCESS CANNULATION SET
Applicant
Research Medical, Inc.
1847 W. 2300 S.
Salt Lake City,  UT  84119
Applicant Contact MICHAEL N KELLY
Correspondent
Research Medical, Inc.
1847 W. 2300 S.
Salt Lake City,  UT  84119
Correspondent Contact MICHAEL N KELLY
Regulation Number870.4210
Classification Product Code
DWF  
Date Received03/20/1989
Decision Date 10/12/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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