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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Introducer, Catheter
510(k) Number K923603
Device Name INTRA-AORTIC BALLOON PUMP CATHETER - MODIFICATION
Applicant
Kontron Instruments, Inc.
9 Plymouth St.
Everett,  MA  02149
Applicant Contact WAYNE P GRIFGIN
Correspondent
Kontron Instruments, Inc.
9 Plymouth St.
Everett,  MA  02149
Correspondent Contact WAYNE P GRIFGIN
Regulation Number870.1340
Classification Product Code
DYB  
Date Received07/02/1992
Decision Date 03/08/1993
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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