DESTINATION RENAL GUIDING SHEATH


Device Classification Name

introducer, catheter

510(k) Number K081045
Device Name DESTINATION RENAL GUIDING SHEATH
Applicant
TERUMO MEDICAL CORP.
950 elkton blvd.
elkton, 
MD 
21921

Applicant Contact mark unterreiner
Correspondent
TERUMO MEDICAL CORP.
950 elkton blvd.
elkton, 
MD 
21921

Correspodent Contact mark unterreiner
Regulation Number 870.1340
Classification Product Code
DYB  
Date Received 04/14/2008
Decision Date 05/28/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No