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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 K111603
Device Name LINEBACKER(TM) TRANSSEPTAL INTRODUCER, 53CM / 62CM / 72CM
Applicant
Ep Dynamics, Inc.
27001 La Paz Rd.
Suite 312
Mission Viejo,  CA  92691
Applicant Contact ALBERT REGO
Correspondent
Ep Dynamics, Inc.
27001 La Paz Rd.
Suite 312
Mission Viejo,  CA  92691
Correspondent Contact ALBERT REGO
Regulation Number870.1340
Classification Product Code
DYB  
Date Received06/08/2011
Decision Date 08/23/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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