Device Classification Name |
prosthesis, vascular graft, of 6mm and greater diameter
|
510(k) Number |
K925123 |
Device Name |
ATRIUM'S HYBRID PTFE |
Applicant |
ATRIUM MEDICAL CORP. |
17 CLINTON DR. |
HOLLIS,
NH
03049
|
|
Applicant Contact |
TED KARWOSKI |
Correspondent |
ATRIUM MEDICAL CORP. |
17 CLINTON DR. |
HOLLIS,
NH
03049
|
|
Correspondent Contact |
TED KARWOSKI |
Regulation Number | 870.3450
|
Classification Product Code |
|
Date Received | 10/13/1992 |
Decision Date | 05/27/1993 |
Decision |
SE - Postmarket Surveillance Required
(SESP) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|