REFLEX BALLON GUIDE CATHETER


Device Classification Name

catheter, percutaneous

510(k) Number K112262
Device Name REFLEX BALLON GUIDE CATHETER
Applicant
REVERSE MEDICAL CORPORATION
13700 alton parkway suite 167
irvine, 
CA 
92618

Applicant Contact jeffrey valko
Correspondent
REVERSE MEDICAL CORPORATION
13700 alton parkway suite 167
irvine, 
CA 
92618

Correspodent Contact jeffrey valko
Regulation Number 870.1250
Classification Product Code
DQY  
Date Received 08/08/2011
Decision Date 11/02/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No