Device Classification Name |
catheter, intravascular, diagnostic
|
510(k) Number |
K770868 |
Device Name |
CATHETER, POLYURETHANE, W/STYLET |
Applicant |
ABBOTT LABORATORIES |
ONE ABBOTT PARK RD. |
ABBOTT PARK,
IL
60064 -3500
|
|
Correspondent |
ABBOTT LABORATORIES |
ONE ABBOTT PARK RD. |
ABBOTT PARK,
IL
60064 -3500
|
|
Regulation Number | 870.1200
|
Classification Product Code |
|
Date Received | 05/12/1977 |
Decision Date | 06/27/1977 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|