Device Classification Name |
catheter, biliary, diagnostic |
|||
---|---|---|---|---|
510(k) Number | K024303 | |||
Device Name | EDWARDS LIFESCIENCES LIFESTENT NT18 SELF-EXPANDING BILIARY STENT AND DELIVERY SYSTEM | |||
Original Applicant |
|
|||
Original Contact | kavin drisko | |||
Regulation Number | 876.5010 | |||
Classification Product Code |
|
|||
Date Received | 12/24/2002 | |||
Decision Date | 07/03/2003 | |||
Decision |
se – with limitations (SESU) |
|||
Regulation Medical Specialty |
Gastroenterology/Urology |
|||
510k Review Panel |
Gastroenterology/Urology |
|||
summary |
summary |
|||
Type | Traditional | |||
Reviewed by Third Party | No | |||
Combination Product |
No |