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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Irrigation
510(k) Number K925533
Device Name ANGESTAT(R) PERICARDIAL DRAINAGE SHEATH SET
Applicant
Angeion Corp.
13000 Hwy. 55
Plymouth,  MN  55441
Applicant Contact BRUCE D HENKE
Correspondent
Angeion Corp.
13000 Hwy. 55
Plymouth,  MN  55441
Correspondent Contact BRUCE D HENKE
Regulation Number878.4200
Classification Product Code
GBX  
Date Received11/02/1992
Decision Date 01/12/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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