| Device Classification Name |
wire, guide, catheter
|
|---|
| 510(K) Number |
K120533 |
|---|
| Models |
M-4000 AND M-4001,
M-5000 AND M-5001,
M-6000, M-6001, M6002, M-6003
|
| Device Name |
BIGBOSS CATHETERS MANTATAY CATHETER MANTARAY GUIDEWIRES |
|---|
| Applicant |
| BRIDGEPOINT MEDICAL |
| 13355 10th ave n, |
| suite #110 |
|
plymouth,
MN
55441
|
|
| Contact |
jill munsinger |
| Regulation Number | 870.1330
|
|---|
| Classification Product Code |
|
|---|
| Subsequent Product Code |
|
|---|
| Date Received | 02/22/2012 |
|---|
| Decision Date | 05/22/2012 |
|---|
| Decision |
substantially equivalent (SE) |
|---|
| Classification Advisory Committee |
Cardiovascular
|
|---|
| Review Advisory Committee |
Cardiovascular
|
|---|
| summary |
summary
|
| Type |
Traditional
|
|---|
| Clinical Trials |
NCT01246505
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Expedited Review |
No
|
|---|
| Combination Product |
No
|
|---|
|
|
