Device Classification Name |
Catheter, Ventricular, General & Plastic Surgery
|
510(k) Number |
K912645 |
Device Name |
ATRIUMS PDR THORACIC CATHETER |
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 | 878.4200
|
Classification Product Code |
|
Date Received | 06/17/1991 |
Decision Date | 09/13/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|