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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Port & Catheter, Implanted, Subcutaneous, Intravascular
510(k) Number K891611
Device Name MODELS 6526,6527,6528 PERCU. TRANS. ANGIO. CATH.
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 Number880.5965
Classification Product Code
LJT  
Date Received03/20/1989
Decision Date 06/12/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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