ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER, MODELS 105-5065 AND 105-5066


Device Classification Name

catheter, continuous flush

510(k) Number K024118
Device Name ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER, MODELS 105-5065 AND 105-5066
Original Applicant
MICRO THERAPEUTICS, INC.
2 goodyear
irvine, 
CA 
92618

Original Contact bill hyatt
Regulation Number 870.1210
Classification Product Code
KRA  
Date Received 12/16/2002
Decision Date 02/03/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls