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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
510(k) Number K883412
Device Name THE CARPENTIER TRANS-MITRAL VENTRICULAR VENT(TM)
Applicant
Promedica Products, Inc.
620 Newport Center Dr.
Suite 575
Newport Beach,  CA  92660
Applicant Contact LEE HAND
Correspondent
Promedica Products, Inc.
620 Newport Center Dr.
Suite 575
Newport Beach,  CA  92660
Correspondent Contact LEE HAND
Regulation Number870.4210
Classification Product Code
DWF  
Date Received08/15/1988
Decision Date 02/08/1989
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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