Device Classification Name |
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
|
510(k) Number |
K864949 |
Device Name |
INSTRUCTION CHANGE FOR RIGHT ATRIAL/RAAF CATHETER |
Applicant |
QUINTON, INC. |
2121 TERRY AVE. |
SEATLE,
WA
98121
|
|
Applicant Contact |
RANDY WALLS |
Correspondent |
QUINTON, INC. |
2121 TERRY AVE. |
SEATLE,
WA
98121
|
|
Correspondent Contact |
RANDY WALLS |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 12/05/1986 |
Decision Date | 02/25/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|