The following data is part of a premarket notification filed by Angiodynamics, Inc. with the FDA for Uni*fuse Infusion System With Cooper Wire.
| Device ID | K192864 |
| 510k Number | K192864 |
| Device Name: | UNI*FUSE Infusion System With Cooper Wire |
| Classification | Catheter, Continuous Flush |
| Applicant | Angiodynamics, Inc. 26 Forest Street Marlborough, MA 01752 |
| Contact | Brandon M. Brackett |
| Correspondent | Brandon M. Brackett Angiodynamics, Inc. 26 Forest Street Marlborough, MA 01752 |
| Product Code | KRA |
| CFR Regulation Number | 870.1210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-07 |
| Decision Date | 2020-06-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15051684023948 | K192864 | 000 |
| 15051684023924 | K192864 | 000 |
| 15051684023900 | K192864 | 000 |
| 15051684023887 | K192864 | 000 |
| 15051684023863 | K192864 | 000 |
| 15051684023849 | K192864 | 000 |
| 15051684023825 | K192864 | 000 |
| 15051684023801 | K192864 | 000 |