ABSOLUTE PRO .035 SELF-EXPANDING STENT SYSTEM


Device Classification Name

catheter, biliary, diagnostic

510(k) Number K072708
Device Name ABSOLUTE PRO .035 SELF-EXPANDING STENT SYSTEM
Applicant
ABBOTT VASCULAR-VASCULAR SOLUTIONS
3200 lakeside dr.
santa clara, 
CA 
95054

Applicant Contact michelle grossman
Correspondent
ABBOTT VASCULAR-VASCULAR SOLUTIONS
3200 lakeside dr.
santa clara, 
CA 
95054

Correspodent Contact michelle grossman
Regulation Number 876.5010
Classification Product Code
FGE  
Date Received 09/25/2007
Decision Date 08/18/2008
Decision

se – with limitations

(SESU)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No