ADMIRAL .035 DILATATION CATHETER, MODELS ADL0720-80,ADL0720-135,ADL0820-80, ADL0820-135,ADL0920-80,ADL0920-135,ADL1020-0


Device Classification Name

catheter, angioplasty, peripheral, transluminal

510(k) Number K030062
Device Name ADMIRAL .035 DILATATION CATHETER, MODELS ADL0720-80,ADL0720-135,ADL0820-80, ADL0820-135,ADL0920-80,ADL0920-135,ADL1020-0
Original Applicant
AVANTEC VASCULAR CORP.
1049 kiel ct.
sunnyvale, 
CA 
94089

Original Contact james m shy
Regulation Number 870.1250
Classification Product Code
LIT  
Date Received 01/07/2003
Decision Date 04/03/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No