Device Classification Name |
Introducer, Catheter
|
510(k) Number |
K900515 |
Device Name |
MODELS 6207/6208/6209/6210/6211/6212/6214 (PLI'S) |
Applicant |
MEDTRONIC VASCULAR |
7000 CENTRAL AVE. N.E. |
MINNEAPOLIS,
MN
55432
|
|
Applicant Contact |
LYNN M NORDSTROM |
Correspondent |
MEDTRONIC VASCULAR |
7000 CENTRAL AVE. N.E. |
MINNEAPOLIS,
MN
55432
|
|
Correspondent Contact |
LYNN M NORDSTROM |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 02/02/1990 |
Decision Date | 08/23/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|