Device Classification Name |
catheter, intravascular, therapeutic, short-term less than 30 days
|
510(k) Number |
K081420 |
Device Name |
VANISHPOINT I.V. CATHETER |
Applicant |
RETRACTABLE TECHNOLOGIES, INC. |
511 LOBO LN. |
LITTLE ELM,
TX
75068 -0009
|
|
Applicant Contact |
RHONDA WELLS |
Correspondent |
RETRACTABLE TECHNOLOGIES, INC. |
511 LOBO LN. |
LITTLE ELM,
TX
75068 -0009
|
|
Correspondent Contact |
RHONDA WELLS |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 05/20/2008 |
Decision Date | 11/07/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|