PERCUTANEOUS INTRODUCER, MODEL 10383-XXX


codes

Device Classification Name

introducer, catheter

510(k) Number K000824
Device Name PERCUTANEOUS INTRODUCER, MODEL 10383-XXX
Original Applicant
MEDAMICUS, INC.
15301 hwy. 55 west
minneapolis, 
MN 
55447

Original Contact dennis madison
Regulation Number 870.1340
Classification Product Code
DYB  
Date Received 03/14/2000
Decision Date 04/13/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

Type Special
Reviewed by Third Party No

Combination Product

No