The following data is part of a premarket notification filed by Angiodynamics, Inc. with the FDA for Unifuse Infusion System With Cooper Wire.
| Device ID | K202347 |
| 510k Number | K202347 |
| Device Name: | UNIFUSE Infusion System With Cooper Wire |
| Classification | Catheter, Continuous Flush |
| Applicant | AngioDynamics, Inc. 26 Forest Street, Suite 200 Marlborough, MA 01752 |
| Contact | Brandon M. Brackett |
| Correspondent | Brandon M. Brackett AngioDynamics, Inc. 26 Forest Street, Suite 200 Marlborough, MA 01752 |
| Product Code | KRA |
| CFR Regulation Number | 870.1210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-18 |
| Decision Date | 2020-09-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15051684023955 | K202347 | 000 |
| H787124018490 | K202347 | 000 |
| H787124018520 | K202347 | 000 |
| H787124018550 | K202347 | 000 |
| H787124018580 | K202347 | 000 |
| H787124018600 | K202347 | 000 |
| H787124018620 | K202347 | 000 |
| H787124018640 | K202347 | 000 |
| 15051684023818 | K202347 | 000 |
| 15051684023832 | K202347 | 000 |
| 15051684023856 | K202347 | 000 |
| 15051684023870 | K202347 | 000 |
| 15051684023894 | K202347 | 000 |
| 15051684023917 | K202347 | 000 |
| 15051684023931 | K202347 | 000 |
| H787124018460 | K202347 | 000 |