SCEPTER C OCCLUSION BALLOON CATHETER


Device Classification Name

catheter, intravascular occluding, temporary

510(k) Number K110741
Device Name SCEPTER C OCCLUSION BALLOON CATHETER
Applicant
MICROVENTION, INC.
1311 valencia ave
tustin, 
CA 
92780

Applicant Contact naomi gong
Correspondent
MICROVENTION, INC.
1311 valencia ave
tustin, 
CA 
92780

Correspodent Contact naomi gong
Regulation Number 870.4450
Classification Product Code
MJN  
Date Received 03/16/2011
Decision Date 09/29/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No