Device Classification Name |
catheter, intravascular, therapeutic, short-term less than 30 days
|
510(k) Number |
K040427 |
Device Name |
FIBREX CATHETER PATENCY DEVICE |
Applicant |
MEDICAL DEVICE TECHNOLOGIES, INC. |
3600 SW 47TH AVENUE |
GAINESVILLE,
FL
32608
|
|
Applicant Contact |
KARL SWARTZ |
Correspondent |
ENTELA, INC. |
3033 MADISON AVENUE, SE |
GRAND RAPIDS,
MI
49548
|
|
Correspondent Contact |
NED DEVINE |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 02/19/2004 |
Decision Date | 05/03/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|