MODIFICATION TO MEDAMICUS AXIA RSN


Device Classification Name

introducer, catheter

510(k) Number K022689
Device Name MODIFICATION TO MEDAMICUS AXIA RSN
Original Applicant
MEDAMICUS, INC.
15301 hwy. 55 west
minneapolis, 
MN 
55447

Original Contact karyl haskell
Regulation Number 870.1340
Classification Product Code
DYB  
Date Received 08/13/2002
Decision Date 08/23/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No