Device Classification Name |
injector and syringe, angiographic
|
510(k) Number |
K984231 |
Device Name |
ANGIOGRAPHIC CONTRAST MANAGEMENT SYSTEM, MODEL PART A AND PART B |
Applicant |
INVASATEC |
7450 FLYING CLOUD DR. |
SUITE 150 |
EDEN PRAIRIE,
MN
55344
|
|
Applicant Contact |
KATE ANDERSON |
Correspondent |
INVASATEC |
7450 FLYING CLOUD DR. |
SUITE 150 |
EDEN PRAIRIE,
MN
55344
|
|
Correspondent Contact |
KATE ANDERSON |
Regulation Number | 870.1650
|
Classification Product Code |
|
Date Received | 11/25/1998 |
Decision Date | 05/31/2000 |
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
|
|
|