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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 K942977
Device Name NOVOSTE PULSE PLUS BLOOD CONTAINMENT DEVICE
Applicant
Novoste Corp.
4350-C International Blvd.
Suite C
Norcross,  GA  30093
Applicant Contact JOAN M MACDONALD
Correspondent
Novoste Corp.
4350-C International Blvd.
Suite C
Norcross,  GA  30093
Correspondent Contact JOAN M MACDONALD
Regulation Number870.1340
Classification Product Code
DYB  
Date Received06/20/1994
Decision Date 12/28/1995
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
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