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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dilator, Vessel, For Percutaneous Catheterization
510(k) Number K896096
Device Name SOLOSTICK (AMPLATZ DILATOR NEEDLE)
Applicant
Microvena Corp.
6470 Riverview Ter.
Findley,  MN  55432
Applicant Contact CONSTANCE G BUNDY
Correspondent
Microvena Corp.
6470 Riverview Ter.
Findley,  MN  55432
Correspondent Contact CONSTANCE G BUNDY
Regulation Number870.1310
Classification Product Code
DRE  
Date Received10/20/1989
Decision Date 04/10/1990
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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