Device Classification Name |
wire, guide, catheter
|
510(k) Number |
K160785 |
Device Name |
Worker Guidewire |
Applicant |
ARGON MEDICAL DEVICES, INC. |
1445 FLAT CREEK ROAD |
ATHENS,
TX
75751
|
|
Applicant Contact |
SUZANNE CHEANG |
Correspondent |
ARGON MEDICAL DEVICES, INC. |
1445 FLAT CREEK ROAD |
ATHENS,
TX
75751
|
|
Correspondent Contact |
SUZANNE CHEANG |
Regulation Number | 870.1330
|
Classification Product Code |
|
Date Received | 03/22/2016 |
Decision Date | 12/08/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|