REVIVE INTERMEDIATE CATHETER (REVIVE IC)


Device Classification Name

catheter, percutaneous

510(k) Number K112828
Device Name REVIVE INTERMEDIATE CATHETER (REVIVE IC)
Applicant
Codman & Shurtleff, Inc.
325 paramount dr.
raynham, 
MA 
02767 -0350

Applicant Contact catherine kilshaw
Correspondent
Codman & Shurtleff, Inc.
325 paramount dr.
raynham, 
MA 
02767 -0350

Correspodent Contact catherine kilshaw
Regulation Number 870.1250
Classification Product Code
DQY  
Date Received 09/28/2011
Decision Date 10/25/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Neurology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No