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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00801741000980 | K052132 | 000 |
| 00801741000805 | K052132 | 000 |
| 00801741000799 | K052132 | 000 |
| 00801741000782 | K052132 | 000 |
| 00801741000775 | K052132 | 000 |
| 00801741000768 | K052132 | 000 |
| 00801741000751 | K052132 | 000 |
| 00801741000744 | K052132 | 000 |
| 00801741000737 | K052132 | 000 |
| 00801741000720 | K052132 | 000 |
| 00801741000713 | K052132 | 000 |
| 00801741000706 | K052132 | 000 |
| 00801741000690 | K052132 | 000 |
| 00801741000683 | K052132 | 000 |
| 00801741000676 | K052132 | 000 |
| 00801741000669 | K052132 | 000 |
| 00801741000812 | K052132 | 000 |
| 00801741000829 | K052132 | 000 |
| 00801741000973 | K052132 | 000 |
| 00801741000966 | K052132 | 000 |
| 00801741000959 | K052132 | 000 |
| 00801741000942 | K052132 | 000 |
| 00801741000935 | K052132 | 000 |
| 00801741000928 | K052132 | 000 |
| 00801741000911 | K052132 | 000 |
| 00801741000904 | K052132 | 000 |
| 00801741000898 | K052132 | 000 |
| 00801741000881 | K052132 | 000 |
| 00801741000874 | K052132 | 000 |
| 00801741000867 | K052132 | 000 |
| 00801741000850 | K052132 | 000 |
| 00801741000843 | K052132 | 000 |
| 00801741000836 | K052132 | 000 |
| 00801741000652 | K052132 | 000 |