| Device Classification Name |
catheter, intravascular, diagnostic
|
| 510(K) Number |
K964210 |
| Device Name |
RETRIEVER II |
| Applicant |
| TARGET THERAPEUTICS |
| 47201 lakeview blvd. |
| p.o. box 5120 |
|
freemont,
CA
94538
|
|
| Contact |
laraine pangelina |
| Regulation Number | 870.1200
|
| Classification Product Code |
|
| Date Received | 10/22/1996 |
| Decision Date | 10/31/1997 |
| Decision |
substantially equivalent (SE) |
| Classification Advisory Committee |
Cardiovascular
|
| Review Advisory Committee |
Cardiovascular
|
| summary |
summary
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Expedited Review |
No
|
| Combination Product |
No
|
|
|