SAFETY INTRODUCER NEEDLE


Device Classification Name

introducer, catheter

510(k) Number K030135
Device Name SAFETY INTRODUCER NEEDLE
Original Applicant
B. BRAUN MEDICAL, INC.
901 marcon blvd.
allentown, 
PA 
18109 -9341

Original Contact amy k smith
Regulation Number 870.1340
Classification Product Code
DYB  
Date Received 01/14/2003
Decision Date 07/15/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No