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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oxygenator, Cardiopulmonary Bypass
510(k) Number K951247
Device Name SPIRALGOLD & SPIRALOXY HOLLOW FIBER OXYGENATORS
Applicant
Baxter Healthcare Corp
17511 Armstrong Ave.
P.O.Box 19522
Irvine,  CA  92713
Applicant Contact SCOTT BEGGINS
Correspondent
Baxter Healthcare Corp
17511 Armstrong Ave.
P.O.Box 19522
Irvine,  CA  92713
Correspondent Contact SCOTT BEGGINS
Regulation Number870.4350
Classification Product Code
DTZ  
Date Received03/20/1995
Decision Date 11/02/1995
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
Recalls CDRH Recalls
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