EDWARDS PERCUTANEOUS SHEATH INTRODUCER

Device Classification Name

introducer, catheter

510(k) Number K121185
Device Name EDWARDS PERCUTANEOUS SHEATH INTRODUCER
Applicant
EDWARDS LIFESCIENCES, LLC.
12050 lone peak pkwy.
draper, 
UT 
84020

Applicant Contact spencer walker
Correspondent
EDWARDS LIFESCIENCES, LLC.
12050 lone peak pkwy.
draper, 
UT 
84020

Correspodent Contact spencer walker
Regulation Number 870.1340
Classification Product Code
DYB  
Date Received 04/18/2012
Decision Date 08/22/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No