SAPPHIRE


Device Classification Name

catheters, transluminal coronary angioplasty, percutaneous

510(k) Number K103657
Device Name SAPPHIRE
Applicant
ORBUSNEICH MEDICAL, INC.
5363 n.w. 35th ave.
ft. lauderdale, 
FL 
33309 -6315

Applicant Contact john pazienza
Correspondent
ORBUSNEICH MEDICAL, INC.
5363 n.w. 35th ave.
ft. lauderdale, 
FL 
33309 -6315

Correspodent Contact john pazienza
Regulation Number 870.5100
Classification Product Code
LOX  
Date Received 12/15/2010
Decision Date 08/09/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No