| Device Classification Name |
Wire, Guide, Catheter
|
|---|
| 510(k) Number |
K920891 |
|---|
| Device Name |
ROADRUNNER(TM) WIRE GUIDE, MODIFICATION |
|---|
| Applicant |
| Cook, Inc. |
| 925 S. Curry Pike |
| P.O. Box 489 |
|
Bloomington,
IN
47402
|
|
| Applicant Contact |
APRIL LAVENDER |
| Correspondent |
| Cook, Inc. |
| 925 S. Curry Pike |
| P.O. Box 489 |
|
Bloomington,
IN
47402
|
|
| Correspondent Contact |
APRIL LAVENDER |
| Regulation Number | 870.1330 |
|---|
| Classification Product Code |
|
|---|
| Date Received | 02/24/1992 |
|---|
| Decision Date | 12/21/1992 |
|---|
| Decision |
Substantially Equivalent
(SESE) |
|---|
| Regulation Medical Specialty |
Cardiovascular
|
|---|
| 510k Review Panel |
Cardiovascular
|
|---|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Combination Product |
No
|
|---|
Predetermined Change
Control Plan Authorized |
No
|
|---|