REVERSE MEDICAL REFLEX GUIDE CATHETER


Device Classification Name

catheter, percutaneous

510(k) Number K110055
Device Name REVERSE MEDICAL REFLEX GUIDE CATHETER
Applicant
REVERSE MEDICAL CORPORATION
13700 alton parkway suite 167
irvine, 
CA 
92618

Applicant Contact amy eskina
Regulation Number 870.1250
Classification Product Code
DQY  
Date Received 01/10/2011
Decision Date 04/05/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No