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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubing, Pump, Cardiopulmonary Bypass
510(k) Number K801394
Device Name CARDIOPULMONARY BYPASS PUMP TUBING
Applicant
Texas Medical Products, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Texas Medical Products, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number870.4390
Classification Product Code
DWE  
Subsequent Product Code
DWB  
Date Received06/13/1980
Decision Date 06/30/1980
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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