GORE(R) DRYSEAL SHEATH WITH HYDROPHILIC COATING


Device Classification Name

introducer, catheter

510(k) Number K121234
Device Name GORE(R) DRYSEAL SHEATH WITH HYDROPHILIC COATING
Applicant
W. L. GORE & ASSOCIATES, INC.
3450 kiltie lane
p.o. box 2400
flagstaff, 
AZ 
86003 -2400

Applicant Contact alicia l hemphill
Correspondent
W. L. GORE & ASSOCIATES, INC.
3450 kiltie lane
p.o. box 2400
flagstaff, 
AZ 
86003 -2400

Correspodent Contact alicia l hemphill
Regulation Number 870.1340
Classification Product Code
DYB  
Date Received 04/24/2012
Decision Date 11/20/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No