MICROCATHETER


Device Classification Name

catheter, intravascular, diagnostic

510(k) Number K112124
Device Name MICROCATHETER
Applicant
NAVILYST MEDICAL, INC.
26 forest street
marlborough, 
MA 
01752

Applicant Contact wanda carpinella
Correspondent
NAVILYST MEDICAL, INC.
26 forest street
marlborough, 
MA 
01752

Correspodent Contact wanda carpinella
Regulation Number 870.1200
Classification Product Code
DQO  
Date Received 07/25/2011
Decision Date 08/19/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No