| Device Classification Name |
catheter, angioplasty, peripheral, transluminal
|
|---|
| 510(K) Number |
K122070 |
|---|
| Model |
CXX-YYY-ZZZZZOTW/CFXX-YYY-ZZZZZ OTW, CXX-YYY-ZZZZZZ OTW / CFXX-YYY-ZZZZZ OTW
|
| Device Name |
CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014" GUIDE WIRE, CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.18" G |
|---|
| Applicant |
| TRIREME MEDICAL INC |
| 7060 knoll center parkway |
| suite 300 |
|
pleasanton,
CA
94566
|
|
| Contact |
shiva ardakani |
| Regulation Number | 870.1250
|
|---|
| Classification Product Code |
|
|---|
| Subsequent Product Code |
|
|---|
| Date Received | 07/16/2012 |
|---|
| Decision Date | 08/15/2012 |
|---|
| 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
|
|---|
|
|
