The following data is part of a premarket notification filed by Puracath Medical, Inc with the FDA for Firefly Needleless Connector.
| Device ID | K203796 |
| 510k Number | K203796 |
| Device Name: | Firefly Needleless Connector |
| Classification | Set, Administration, Intravascular |
| Applicant | PuraCath Medical, Inc 37600 Central Court, Suite 210 Newark, CA 94560 |
| Contact | Julia Rasooly |
| Correspondent | Julia Rasooly PuraCath Medical, Inc 37600 Central Court, Suite 210 Newark, CA 94560 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-28 |
| Decision Date | 2021-07-30 |