PACIFIC XTREME PTCA BALLOON DILATATION CATHETER


Device Classification Name

catheter, angioplasty, peripheral, transluminal

510(k) Number K103464
Device Name PACIFIC XTREME PTCA BALLOON DILATATION CATHETER
Applicant
MEDTRONIC INC.
37a cherry hill drive
danvers, 
MA 
01923

Applicant Contact heather morose
Correspondent
MEDTRONIC INC.
37a cherry hill drive
danvers, 
MA 
01923

Correspodent Contact heather morose
Regulation Number 870.1250
Classification Product Code
LIT  
Subsequent Product Code
DQY  
Date Received 11/24/2010
Decision Date 12/22/2010
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No