RUNTHROUGH NS EXTENSION WIRE


Device Classification Name

wire, guide, catheter

510(k) Number K080563
Device Name RUNTHROUGH NS EXTENSION WIRE
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 870.1330
Classification Product Code
DQX  
Date Received 02/28/2008
Decision Date 03/20/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No