SUREFIRE INFUSION CATHETER SYSTEM


Device Classification Name

catheter, intravascular, diagnostic

510(k) Number K110459
Device Name SUREFIRE INFUSION CATHETER SYSTEM
Applicant
SUREFIRE MEDICAL, INC
8601 turnpike dr
suite 206
westminister, 
CO 
80031

Applicant Contact cheryl hastings
Correspondent
SUREFIRE MEDICAL, INC
8601 turnpike dr
suite 206
westminister, 
CO 
80031

Correspodent Contact cheryl hastings
Regulation Number 870.1200
Classification Product Code
DQO  
Date Received 02/17/2011
Decision Date 06/24/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No