COAXIA FLOCONTROL CATHETER


Device Classification Name

catheter, intravascular occluding, temporary

510(k) Number K023914
Device Name COAXIA FLOCONTROL CATHETER
Original Applicant
COAXIA INC
10900 73rd ave. n.
maple grove, 
MN 
55369

Original Contact gregory w sachs
Regulation Number 870.4450
Classification Product Code
MJN  
Date Received 11/25/2002
Decision Date 02/21/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No