TERUMO ASPRIATION CATHETER


Device Classification Name

catheter, embolectomy

510(k) Number K112382
Device Name TERUMO ASPRIATION CATHETER
Applicant
Terumo Medical Corporation
950 elkton blvd
elkton, 
MD 
21921

Applicant Contact daniel r plonski
Regulation Number 870.5150
Classification Product Code
DXE  
Date Received 08/18/2011
Decision Date 12/14/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No