REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETER


Device Classification Name

reprocessed intravascular ultrasound catheter

510(k) Number K110076
Device Name REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETER
Applicant
STERILMED, INC.
11400 73rd ave. north
maple grove, 
MN 
55369 -5562

Applicant Contact garrett ahlborg
Correspondent
STERILMED, INC.
11400 73rd ave. north
maple grove, 
MN 
55369 -5562

Correspodent Contact garrett ahlborg
Regulation Number 870.1200
Classification Product Code
OWQ  
Date Received 01/11/2011
Decision Date 08/18/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls