MODIFICATION TO HYPERGLIDE OCCLUSION BALLOON SYSTEM


Device Classification Name

catheter, intravascular occluding, temporary

510(k) Number K021066
Device Name MODIFICATION TO HYPERGLIDE OCCLUSION BALLOON SYSTEM
Original Applicant
MICRO THERAPEUTICS, INC.
2 goodyear
irvine, 
CA 
92618

Original Contact tom daughters
Regulation Number 870.4450
Classification Product Code
MJN  
Date Received 04/02/2002
Decision Date 06/18/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No