Z FLEX-270TM STEERABLE SHEATH


Device Classification Name

catheter, steerable

510(k) Number K112541
Device Name Z FLEX-270TM STEERABLE SHEATH
Applicant
Greatbatch Medical
2300 berkshire lane north
minneapolis, 
MN 
55441

Applicant Contact sara bakker
Correspondent
Greatbatch Medical
2300 berkshire lane north
minneapolis, 
MN 
55441

Correspodent Contact sara bakker
Regulation Number 870.1280
Classification Product Code
DRA  
Date Received 09/01/2011
Decision Date 02/07/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls