| Device Classification Name |
Catheter, Intravascular Occluding, Temporary
|
|---|
| 510(k) Number |
K001237 |
|---|
| Device Name |
EQUINOX OCCLUSION BALLOON CATHETER/SYSTEM - (10MM BALLOON, 4 & 13 MM TIP), (15 MM BALLOON, 4 & 13 MM TIP), (20 MM BALLOO |
|---|
| Applicant |
| Micro Therapeutics, Inc. |
| 2 Goodyear |
|
Irvine,
CA
92618
|
|
| Applicant Contact |
TOM DAUGHTERS |
| Correspondent |
| Micro Therapeutics, Inc. |
| 2 Goodyear |
|
Irvine,
CA
92618
|
|
| Correspondent Contact |
TOM DAUGHTERS |
| Regulation Number | 870.4450 |
|---|
| Classification Product Code |
|
|---|
| Date Received | 04/18/2000 |
|---|
| Decision Date | 05/18/2000 |
|---|
| Decision |
Substantially Equivalent
(SESE) |
|---|
| Regulation Medical Specialty |
Cardiovascular
|
|---|
| 510k Review Panel |
Cardiovascular
|
|---|
| Type |
Special
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Combination Product |
No
|
|---|
Predetermined Change
Control Plan Authorized |
No
|
|---|