ARMADA 35/35LL PTA CATHETER


Device Classification Name

catheter, angioplasty, peripheral, transluminal

510(k) Number K111899
Device Name ARMADA 35/35LL PTA CATHETER
Applicant
Abbott Vascular
3200 lakeside drive
santa clara, 
CA 
95054

Applicant Contact laarni ricafort
Correspondent
Abbott Vascular
3200 lakeside drive
santa clara, 
CA 
95054

Correspodent Contact laarni ricafort
Regulation Number 870.1250
Classification Product Code
LIT  
Subsequent Product Code
DQY  
Date Received 07/05/2011
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

Recalls CDRH Recalls