| Device Classification Name |
introducer, catheter
|
| 510(k) Number |
K913801 |
| Device Name |
CORDIS CATH SHEATH INTRO SYST PLUS W/UNISTASIS VAL |
| Applicant |
| CORDIS CORP. |
| 14201 N.W. 60TH AVE. |
|
miami lakes,
FL
33014
|
|
| Applicant Contact |
mirjam barboza |
| Correspondent |
| CORDIS CORP. |
| 14201 N.W. 60TH AVE. |
|
miami lakes,
FL
33014
|
|
| Correspondent Contact |
mirjam barboza |
| Regulation Number | 870.1340
|
| Classification Product Code |
|
| Date Received | 08/26/1991 |
| Decision Date | 10/16/1991 |
| Decision |
substantially equivalent
(SESE) |
| Regulation Medical Specialty |
Cardiovascular
|
| 510k Review Panel |
Cardiovascular
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
|
|