Device Classification Name |
catheter, intravascular, therapeutic, long-term greater than 30 days
|
510(k) Number |
K071875 |
Device Name |
V-CATH POLY PICC |
Applicant |
HDC CORP. |
628 GIBRALTAR CT. |
MILPITAS,
CA
95035
|
|
Applicant Contact |
EARL SMART |
Correspondent |
HDC CORP. |
628 GIBRALTAR CT. |
MILPITAS,
CA
95035
|
|
Correspondent Contact |
EARL SMART |
Regulation Number | 880.5970
|
Classification Product Code |
|
Date Received | 07/06/2007 |
Decision Date | 11/05/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|