TITAN MICRO CATHETER, MODEL 105-5074-153; HD INJECTOR, MODEL 103-0305


Device Classification Name

introducer, catheter

510(k) Number K022003
Device Name TITAN MICRO CATHETER, MODEL 105-5074-153; HD INJECTOR, MODEL 103-0305
Original Applicant
MICRO THERAPEUTICS, INC.
2 goodyear
irvine, 
CA 
92618

Original Contact bill hyatt
Regulation Number 870.1340
Classification Product Code
DYB  
Subsequent Product Code
DQF  
Date Received 06/19/2002
Decision Date 09/13/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No