Device Classification Name |
flowmeter, blood, cardiovascular
|
510(k) Number |
K033424 |
Device Name |
ANGIOFLOW METER, ANGIOFLOW ANTEGRADE CATHETER, ANGIOFLOW RETROGRADE CATHETER, MODELS HVT100, ADT1001, ADT1002 |
Applicant |
TRANSONIC SYSTEMS, INC. |
34 DUTCH MILL RD. |
ITHACA,
NY
14850
|
|
Applicant Contact |
MARK S ALSBERGE |
Correspondent |
TRANSONIC SYSTEMS, INC. |
34 DUTCH MILL RD. |
ITHACA,
NY
14850
|
|
Correspondent Contact |
MARK S ALSBERGE |
Regulation Number | 870.2100
|
Classification Product Code |
|
Date Received | 10/23/2003 |
Decision Date | 12/11/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|