Device Classification Name |
introducer, catheter
|
510(k) Number |
K941428 |
Device Name |
EXACTA PERCUTANEOUS INTRODUCER SHEATH |
Applicant |
OHMEDA MEDICAL |
1911 WILLIAMS DR. |
OXNARD,
CA
93030 -2629
|
|
Applicant Contact |
CHERYL L SHEA |
Correspondent |
OHMEDA MEDICAL |
1911 WILLIAMS DR. |
OXNARD,
CA
93030 -2629
|
|
Correspondent Contact |
CHERYL L SHEA |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 03/24/1994 |
Decision Date | 07/06/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|