Device Classification Name |
wire, guide, catheter
|
510(k) Number |
K053251 |
Device Name |
TECHDEVICE GUIDEWIRE |
Applicant |
TECHDEVICE CORPORATION |
650 PLEASANT ST. |
WATERTOWN,
MA
02472
|
|
Applicant Contact |
LEIGH HAYWARD |
Correspondent |
TECHDEVICE CORPORATION |
650 PLEASANT ST. |
WATERTOWN,
MA
02472
|
|
Correspondent Contact |
LEIGH HAYWARD |
Regulation Number | 870.1330
|
Classification Product Code |
|
Date Received | 11/21/2005 |
Decision Date | 03/08/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|