EXTRA PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE; PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE


Device Classification Name

catheter, percutaneous

510(k) Number K111750
Device Name EXTRA PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE; PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE
Applicant
ANGIOSLIDE, LTD
11925 west i-70 frontage rd
north suite 900
clay anselmo, 
CO 
80033

Applicant Contact clay anselmo
Correspondent
ANGIOSLIDE, LTD
11925 west i-70 frontage rd
north suite 900
clay anselmo, 
CO 
80033

Correspodent Contact clay anselmo
Regulation Number 870.1250
Classification Product Code
DQY  
Subsequent Product Code
LIT  
Date Received 06/22/2011
Decision Date 07/21/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No