GLIDECROSS SUPPORT CATHETER


Device Classification Name

catheter, percutaneous

510(k) Number K111556
Device Name GLIDECROSS SUPPORT CATHETER
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 870.1250
Classification Product Code
DQY  
Date Received 06/06/2011
Decision Date 07/29/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No