MEDTRONIC VASCULAR – HUB MATERIAL MODIFICATION TO THE 5F AND 8F LAUNCHER(R) GUIDE CATHETERS


Device Classification Name

catheter, percutaneous

510(k) Number K103386
Device Name MEDTRONIC VASCULAR – HUB MATERIAL MODIFICATION TO THE 5F AND 8F LAUNCHER(R) GUIDE CATHETERS
Applicant
MEDTRONIC INC.
35-37a cherry hill drive
danvers, 
MA 
01923 -5186

Applicant Contact anu gaur
Correspondent
MEDTRONIC INC.
35-37a cherry hill drive
danvers, 
MA 
01923 -5186

Correspodent Contact anu gaur
Regulation Number 870.1250
Classification Product Code
DQY  
Date Received 11/18/2010
Decision Date 02/11/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls