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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 K034025
Device Name NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC
Applicant
Nmt Medical, Inc.
27-43 Wormwood St.
Boston,  MA  02210
Applicant Contact ANNE M KULIS
Correspondent
Nmt Medical, Inc.
27-43 Wormwood St.
Boston,  MA  02210
Correspondent Contact ANNE M KULIS
Regulation Number870.1340
Classification Product Code
DYB  
Date Received12/29/2003
Decision Date 03/26/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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