The following data is part of a premarket notification filed by Angiodynamics, Inc. with the FDA for Angiodynamics Total Abscession Biliary Drainage Catheter.
| Device ID | K170743 |
| 510k Number | K170743 |
| Device Name: | AngioDynamics Total Abscession Biliary Drainage Catheter |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | AngioDynamics, Inc. 603 Queensbury Avenue Queensbury, NY 12804 |
| Contact | Teri Juckett |
| Correspondent | Teri Juckett AngioDynamics, Inc. 603 Queensbury Avenue Queensbury, NY 12804 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-10 |
| Decision Date | 2017-03-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 25051684011706 | K170743 | 000 |
| 25051684011690 | K170743 | 000 |
| 25051684011683 | K170743 | 000 |
| 25051684011676 | K170743 | 000 |