Device Classification Name |
introducer, catheter
|
510(k) Number |
K031922 |
Device Name |
CAPTIVA BLOOD CONTAINMENT DEVICE CN100, CAN19T71W |
Applicant |
MERIT MEDICAL SYSTEMS, INC. |
1600 WEST MERIT PKWY. |
SOUTH JORDAN,
UT
84095
|
|
Applicant Contact |
JOHN W NICHOLSON |
Correspondent |
MERIT MEDICAL SYSTEMS, INC. |
1600 WEST MERIT PKWY. |
SOUTH JORDAN,
UT
84095
|
|
Correspondent Contact |
JOHN W NICHOLSON |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 06/23/2003 |
Decision Date | 10/01/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|