Device Classification Name |
introducer, catheter
|
510(k) Number |
K770561 |
Device Name |
CATHETER,PERCUTANEOUS INTRODUC. & SHEATH |
Applicant |
USCI, DIV. C.R. BARD, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
USCI, DIV. C.R. BARD, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 03/23/1977 |
Decision Date | 04/26/1977 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|