TRIV(TM) VALVED TEARAWAY INTRODUCER, TIRV(TM) VALVED TEARAWAY INTRODUCER WITH SIDE PORT


Device Classification Name

introducer, catheter

510(k) Number K112398
Device Name TRIV(TM) VALVED TEARAWAY INTRODUCER, TIRV(TM) VALVED TEARAWAY INTRODUCER WITH SIDE PORT
Applicant
GALT MEDICAL
5203 bristol industrial way
buford, 
GA 
30518

Applicant Contact betsy cortelloni
Correspondent
GALT MEDICAL
5203 bristol industrial way
buford, 
GA 
30518

Correspodent Contact betsy cortelloni
Regulation Number 870.1340
Classification Product Code
DYB  
Date Received 08/19/2011
Decision Date 04/12/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls