Device Classification Name |
introducer, catheter
|
510(k) Number |
K042036 |
Device Name |
AIRGUARD VALVED INTRODUCER |
Applicant |
C.R. BARD, INC. |
5425 WEST AMELIA EARHART DR. |
SALT LAKE CITY,
UT
84116
|
|
Applicant Contact |
GLENN NORTON |
Correspondent |
CITECH |
5200 BUTLER PIKE |
PLYMOUTH MEETING,
PA
19462 -1298
|
|
Correspondent Contact |
JAMES MURPHY |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 07/29/2004 |
Decision Date | 08/23/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|