Device Classification Name |
stents, drains and dilators for the biliary ducts
|
510(k) Number |
K032768 |
Device Name |
MEDTRONIC, INC. RACER BILIARY STENT SYSTEM (RACER), MODEL XD#YF(L) |
Applicant |
MEDTRONIC AVE, INC. |
3576 Unocal Place |
Santa Rosa,
CA
95403
|
|
Applicant Contact |
SARAH SHEPHARD |
Correspondent |
MEDTRONIC AVE, INC. |
3576 Unocal Place |
Santa Rosa,
CA
95403
|
|
Correspondent Contact |
SARAH SHEPHARD |
Regulation Number | 876.5010
|
Classification Product Code |
|
Date Received | 09/08/2003 |
Decision Date | 10/09/2003 |
Decision |
SE - With Limitations
(SESU) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|