Device Classification Name |
catheter, cannula and tubing, vascular, cardiopulmonary bypass
|
510(k) Number |
K862190 |
Device Name |
WALRUS: DOUBLE BALLOON SHUNTING CATHETER |
Applicant |
MEDICAL PARAMETERS, INC. |
20 CABOT RD. |
WOBURN,
MA
01801
|
|
Applicant Contact |
WALTER MACEACHERN |
Correspondent |
MEDICAL PARAMETERS, INC. |
20 CABOT RD. |
WOBURN,
MA
01801
|
|
Correspondent Contact |
WALTER MACEACHERN |
Regulation Number | 870.4210
|
Classification Product Code |
|
Date Received | 06/09/1986 |
Decision Date | 11/03/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|