Device Classification Name |
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
|
510(k) Number |
K926293 |
Device Name |
ANGIOCOR SIDEHOLE INFUSION CATHETER |
Applicant |
ANGIOCOR |
55 NORTHERN BLVD. |
SUITE 301 |
GREAT NECK,
NY
11021
|
|
Applicant Contact |
ANAND AKERKAR |
Correspondent |
ANGIOCOR |
55 NORTHERN BLVD. |
SUITE 301 |
GREAT NECK,
NY
11021
|
|
Correspondent Contact |
ANAND AKERKAR |
Regulation Number | 880.5970 |
Classification Product Code |
|
Date Received | 12/14/1992 |
Decision Date | 03/07/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|