Device Classification Name |
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
|
510(k) Number |
K983409 |
Device Name |
V-CATH PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) SEE APPENDIX 1 |
Applicant |
HDC CORP. |
2109 O'TOOLE AVE. |
SAN JOSE,
CA
95131
|
|
Applicant Contact |
JAMES S ABILLA |
Correspondent |
HDC CORP. |
2109 O'TOOLE AVE. |
SAN JOSE,
CA
95131
|
|
Correspondent Contact |
JAMES S ABILLA |
Regulation Number | 880.5200 |
Classification Product Code |
|
Date Received | 09/28/1998 |
Decision Date | 10/16/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|