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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 K002054
Device Name X-SEPT TRANSSEPTAL SHEATH AND TRANSITION CATHETER, MODEL MV-03-09-90, MV-03-10-90, MV-03-11-90, MV-03-09-120, MV-03-10-1
Applicant
Appriva Medical, Inc.
777 N. Pastoria Ave.
Sunnyvale,  CA  94086
Applicant Contact MICHAEL KOLBER
Correspondent
Appriva Medical, Inc.
777 N. Pastoria Ave.
Sunnyvale,  CA  94086
Correspondent Contact MICHAEL KOLBER
Regulation Number870.1340
Classification Product Code
DYB  
Date Received07/06/2000
Decision Date 02/16/2001
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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