Device Classification Name |
Introducer, Catheter
|
510(k) Number |
K914046 |
Device Name |
THE BIG EASY Y-ADAPTER |
Applicant |
MICROVENA CORP. |
3600 LABORE RD. #1 |
VADNAIS HEIGHTS,
MN
55110
|
|
Applicant Contact |
RUDY MAZZOCCHI |
Correspondent |
MICROVENA CORP. |
3600 LABORE RD. #1 |
VADNAIS HEIGHTS,
MN
55110
|
|
Correspondent Contact |
RUDY MAZZOCCHI |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 09/10/1991 |
Decision Date | 11/08/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|