PINNACLE PRECISION ACCESS SYSTEM


Device Classification Name

introducer, catheter

510(k) Number K111606
Device Name PINNACLE PRECISION ACCESS SYSTEM
Applicant
TERUMO MEDICAL CORP.
950 elkton blvd.
elkton, 
MD 
21921

Applicant Contact daniel r plonski
Correspondent
TERUMO MEDICAL CORP.
950 elkton blvd.
elkton, 
MD 
21921

Correspodent Contact daniel r plonski
Regulation Number 870.1340
Classification Product Code
DYB  
Date Received 06/09/2011
Decision Date 10/03/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No