EBONY PTA .035 PERIPHERAL DILATATION CATHETER


Device Classification Name

catheter, angioplasty, peripheral, transluminal

510(k) Number K103354
Device Name EBONY PTA .035 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  
Date Received 11/16/2010
Decision Date 02/23/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No