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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Balloon Inflation
510(k) Number K921757
Device Name ANGEION IGITAL ANGEFLATOR
Applicant
Angeion Corp.
13000 Hwy. 55
Plymouth,  MN  55441
Applicant Contact STEVEN W HUNTLEY
Correspondent
Angeion Corp.
13000 Hwy. 55
Plymouth,  MN  55441
Correspondent Contact STEVEN W HUNTLEY
Regulation Number870.1650
Classification Product Code
MAV  
Date Received04/13/1992
Decision Date 03/18/1993
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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