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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 K961717
Device Name NMI RETROGRADE CARDIOPLEGIA CANNULA-RCCS
Applicant
Naltiac Medical, Inc.
17194 Preston Rd.
Suite 123-206
Dallas,  TX  75248
Applicant Contact WENDEL LLOYD
Correspondent
Naltiac Medical, Inc.
17194 Preston Rd.
Suite 123-206
Dallas,  TX  75248
Correspondent Contact WENDEL LLOYD
Regulation Number870.4210
Classification Product Code
DWF  
Date Received05/02/1996
Decision Date 07/18/1996
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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