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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 K931489
Device Name INTHERM RADIALLY EXPANDING DILATING INTRODUCER
Applicant
Innerdyne Medical, Inc.
2665 Marine Way
Mountain View,  CA  94043
Applicant Contact COLIN J NICHOLS
Correspondent
Innerdyne Medical, Inc.
2665 Marine Way
Mountain View,  CA  94043
Correspondent Contact COLIN J NICHOLS
Regulation Number870.1340
Classification Product Code
DYB  
Date Received03/25/1993
Decision Date 10/15/1993
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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