INVISIPORT


Device Classification Name

port & catheter, implanted, subcutaneous, intravascular

510(k) Number K110407
Device Name INVISIPORT
Applicant
STEALTH THERAPEUTICS, INCORPORATED
800 levanger lane
stoughton, 
WI 
53589

Applicant Contact gary j syring
Correspondent
STEALTH THERAPEUTICS, INCORPORATED
800 levanger lane
stoughton, 
WI 
53589

Correspodent Contact gary j syring
Regulation Number 880.5965
Classification Product Code
LJT  
Date Received 02/14/2011
Decision Date 10/13/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No