510(k) Premarket Notification Database
Device Classification Name |
catheter, angioplasty, peripheral, transluminal
|
510(k) Number | K904984 |
Device Name | ADVANCE 418(TM) |
Applicant |
PERIPHERAL SYSTEMS GROUP
|
1395 charleston rd. |
mountain view,
CA
94043 |
|
Contact | jessica ayres |
Regulation Number | 870.1250 |
Classification Product Code |
|
Date Received | 11/02/1990 |
Decision Date | 04/12/1991 |
Decision |
substantially equivalent (SE) |
Classification Advisory Committee |
Cardiovascular
|
Review Advisory Committee |
Cardiovascular
|
Statement/Summary/Purged Status |
Purged, no summary or statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Expedited Review |
|
|
|