SUREFIRE HIGH FLOW ANGIOGRAPHIC CATHETER, ACCESS


Device Classification Name

wire, guide, catheter

510(k) Number K122506
Device Name SUREFIRE HIGH FLOW ANGIOGRAPHIC CATHETER, ACCESS
Applicant
SUREFIRE MEDICAL, INC
12415 sw 136 avenue
unit 3
miami, 
FL 
33186

Applicant Contact mario arbesu
Regulation Number 870.1330
Classification Product Code
DQX  
Date Received 08/17/2012
Decision Date 09/17/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No