SUREFIRE HI-FLOW MICROCATHETER


Device Classification Name

catheter, intravascular, diagnostic

510(k) Number K121677
Device Name SUREFIRE HI-FLOW MICROCATHETER
Applicant
SUREFIRE MEDICAL, INC.
12415 sw 136 avenue
unit 3
miami, 
FL 
33186

Applicant Contact mario arbesu
Regulation Number 870.1200
Classification Product Code
DQO  
Date Received 06/07/2012
Decision Date 06/14/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No