LINEBACKER(TM) TRANSSEPTAL INTRODUCER, 53CM / 62CM / 72CM


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 road
suite #312
mission viejo, 
CA 
92691

Applicant Contact albert rego
Correspondent
EP DYNAMICS, INC.
27001 la paz road
suite #312
mission viejo, 
CA 
92691

Correspodent Contact albert rego
Regulation Number 870.1340
Classification Product Code
DYB  
Date Received 06/08/2011
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