ACUNAV 90/10 DIAGNOSTIC ULTRASOUND CATHETER

Device Classification Name

catheter, ultrasound, intravascular

510(k) Number K033650
Device Name ACUNAV 90/10 DIAGNOSTIC ULTRASOUND CATHETER
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
1230 shorebird way
mountain view, 
CA 
94039 -7393

Applicant Contact iskra mrakovic
Correspondent
SIEMENS MEDICAL SOLUTIONS USA, INC.
1230 shorebird way
mountain view, 
CA 
94039 -7393

Correspodent Contact iskra mrakovic
Regulation Number 870.1200
Classification Product Code
OBJ  
Subsequent Product Code
ITX  
Date Received 11/20/2003
Decision Date 02/24/2004
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls