EBONY PTA 0.014 PERIPHERAL DILATATION CATHETER


Device Classification Name

catheter, angioplasty, peripheral, transluminal

510(k) Number K112513
Device Name EBONY PTA 0.014 PERIPHERAL DILATATION CATHETER
Applicant
NATEC MEDICAL LTD
1468 harwell avenue
crofton, 
MD 
21114

Applicant Contact e.j. smith
Correspondent
NATEC MEDICAL LTD
1468 harwell avenue
crofton, 
MD 
21114

Correspodent Contact e.j. smith
Regulation Number 870.1250
Classification Product Code
LIT  
Subsequent Product Code
DQY  
Date Received 08/30/2011
Decision Date 12/09/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No