NC QUANTUM APEX PTCA DILATATION CATHETER (MONORAIL)


Device Classification Name

catheters, transluminal coronary angioplasty, percutaneous

510(k) Number K121667
Device Name NC QUANTUM APEX PTCA DILATATION CATHETER (MONORAIL)
Applicant
BOSTON SCIENTIFIC CORP.
one scimed place
maple grove, 
MN 
55311 -1566

Applicant Contact laura j lind
Correspondent
BOSTON SCIENTIFIC CORP.
one scimed place
maple grove, 
MN 
55311 -1566

Correspodent Contact laura j lind
Regulation Number 870.5100
Classification Product Code
LOX  
Date Received 06/06/2012
Decision Date 08/13/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No