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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Injector And Syringe, Angiographic
510(k) Number K890898
Device Name MODEL 611101 CONTRAST INJECTION DEVICE
Applicant
Medtronic Versaflex, Inc.
4060 Sorrento Valley Blvd.
San Diego,  CA  92121
Applicant Contact TIMOTHY J JOHNSON
Correspondent
Medtronic Versaflex, Inc.
4060 Sorrento Valley Blvd.
San Diego,  CA  92121
Correspondent Contact TIMOTHY J JOHNSON
Regulation Number870.1650
Classification Product Code
DXT  
Date Received02/22/1989
Decision Date 04/12/1989
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
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