INTROCAN SAFETY (R) 3 CLOSED IV CATHETER 18GA X 1-3/4 (45MM) AND 18GA X 1-1/4 (32MM) / 20GA X 1-1/4 (32MM) / 20GA X 1


Device Classification Name

catheter,intravascular,therapeutic,short-term less than 30 days

510(k) Number K111236
Device Name INTROCAN SAFETY (R) 3 CLOSED IV CATHETER 18GA X 1-3/4 (45MM) AND 18GA X 1-1/4 (32MM) / 20GA X 1-1/4 (32MM) / 20GA X 1
Applicant
B. BRAUN MELSUNGEN AG
901 marcon blvd
allentown, 
PA 
18109

Applicant Contact angela j caravella
Correspondent
B. BRAUN MELSUNGEN AG
901 marcon blvd
allentown, 
PA 
18109

Correspodent Contact angela j caravella
Regulation Number 880.5200
Classification Product Code
FOZ  
Date Received 05/02/2011
Decision Date 08/30/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No