MOBICATH TRANSSEPTAL NEEDLE


Device Classification Name

trocar

510(k) Number K111644
Device Name MOBICATH TRANSSEPTAL NEEDLE
Applicant
Greatbatch Medical
2300 berkshire lane north
minneapolis, 
MN 
55441

Applicant Contact kristi fox
Correspondent
Greatbatch Medical
2300 berkshire lane north
minneapolis, 
MN 
55441

Correspodent Contact kristi fox
Regulation Number 870.1390
Classification Product Code
DRC  
Date Received 06/13/2011
Decision Date 10/03/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No