Device Classification Name |
catheter, intravascular, diagnostic
|
510(k) Number |
K000659 |
Device Name |
MODIFICATION TO SOFTOUCH DIAGNOSTIC INTRAVASCULAR CAT |
Applicant |
MERIT MEDICAL SYSTEMS, INC. |
1111 SOUTH VELASCO |
ANGLETON,
TX
77515
|
|
Applicant Contact |
CHESTER MCCOY |
Correspondent |
MERIT MEDICAL SYSTEMS, INC. |
1111 SOUTH VELASCO |
ANGLETON,
TX
77515
|
|
Correspondent Contact |
CHESTER MCCOY |
Regulation Number | 870.1200
|
Classification Product Code |
|
Date Received | 02/28/2000 |
Decision Date | 03/29/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|