The following data is part of a premarket notification filed by Angiodynamics, Inc. with the FDA for Speedlyser Infusion Catheter.
| Device ID | K170258 |
| 510k Number | K170258 |
| Device Name: | SpeedLyser Infusion Catheter |
| Classification | Catheter, Continuous Flush |
| 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 | KRA |
| CFR Regulation Number | 870.1210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-27 |
| Decision Date | 2017-02-21 |
| Summary: | summary |