The following data is part of a premarket notification filed by Edwards Lifesciences, Llc. with the FDA for Modification To: Lifestent Valeo Biliary Stent System.
Device ID | K052132 |
510k Number | K052132 |
Device Name: | MODIFICATION TO: LIFESTENT VALEO BILIARY STENT SYSTEM |
Classification | Stents, Drains And Dilators For The Biliary Ducts |
Applicant | EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY Irvine, CA 92614 |
Contact | Kevin Drisko |
Correspondent | Kevin Drisko EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY Irvine, CA 92614 |
Product Code | FGE |
CFR Regulation Number | 876.5010 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-08-05 |
Decision Date | 2005-08-24 |
Summary: | summary |