Device Classification Name |
Wire, Guide, Catheter
|
510(k) Number |
K101339 |
Device Name |
ARCHER SUPER STIFF GUIDEWIRES |
Applicant |
MEDTRONIC INC. |
3576 Unocal Place |
Santa Rosa,
CA
95403
|
|
Applicant Contact |
COLLEEN MULLINS |
Correspondent |
MEDTRONIC INC. |
3576 Unocal Place |
Santa Rosa,
CA
95403
|
|
Correspondent Contact |
COLLEEN MULLINS |
Regulation Number | 870.1330
|
Classification Product Code |
|
Date Received | 05/12/2010 |
Decision Date | 08/31/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|