| Device Classification Name |
wire, guide, catheter
|
|---|
| 510(K) Number |
K122590 |
|---|
| Model |
RA FA14181C (GA1418), RA FA14301C (GA1430)
|
| Device Name |
RADIFOCUS GLIDEWIRE ADVANTAGE, RADIFOCUS GLIDEWIRE ADVANTAGE |
|---|
| Applicant |
| TERUMO MEDICAL CORPORATION |
| 265 davidson ave, ste 320 |
|
somerset,
NJ
08873
|
|
| Contact |
stacy a kluesner, ms, rac |
| Regulation Number | 870.1330
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 08/24/2012 |
|---|
| Decision Date | 03/01/2013 |
|---|
| Decision |
substantially equivalent (SE) |
|---|
| Classification Advisory Committee |
Cardiovascular
|
|---|
| Review Advisory Committee |
Cardiovascular
|
|---|
| summary |
summary
|
| Type |
Special
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Expedited Review |
No
|
|---|
| Combination Product |
No
|
|---|
|
|
