The following data is part of a premarket notification filed by Angiotech with the FDA for Skater Biliary Catheter.
| Device ID | K070610 |
| 510k Number | K070610 |
| Device Name: | SKATER BILIARY CATHETER |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | ANGIOTECH 13921 PARK CENTER ROAD SUITE 100 Herndon, VA 20171 |
| Contact | Trudy Estridge |
| Correspondent | Trudy Estridge ANGIOTECH 13921 PARK CENTER ROAD SUITE 100 Herndon, VA 20171 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-05 |
| Decision Date | 2007-06-21 |
| Summary: | summary |