FLOWLINE BIOPORE EPTFE VASCULAR GRAFT


Device Classification Name

prosthesis, vascular graft, of 6mm and greater diameter

510(k) Number K021547
Device Name FLOWLINE BIOPORE EPTFE VASCULAR GRAFT
Original Applicant
JOTEC GMBH
2430 n. 7th ave. ste 4
bozeman, 
MT 
59715

Original Contact joe sharber
Regulation Number 870.3450
Classification Product Code
DSY  
Date Received 05/10/2002
Decision Date 01/24/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No