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 | K060023 |
| 510k Number | K060023 |
| Device Name: | ANGIODYNAMICS TOTAL ABSCESSION BILIARY DRAINAGE CATHETER |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | ANGIODYNAMICS, INC. 603 QUEENSBURY AVE. Queensbury, NY 12804 |
| Contact | Teri Juckett |
| Correspondent | Teri Juckett ANGIODYNAMICS, INC. 603 QUEENSBURY AVE. 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 | 2006-01-04 |
| Decision Date | 2006-03-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H787140009045 | K060023 | 000 |
| H787140009035 | K060023 | 000 |
| H787140009025 | K060023 | 000 |
| H787140009015 | K060023 | 000 |