The following data is part of a premarket notification filed by Puracath Medical, Inc. with the FDA for Firefly Peritoneal Dialysis Connector Disinfection System.
| Device ID | K151620 |
| 510k Number | K151620 |
| Device Name: | Firefly Peritoneal Dialysis Connector Disinfection System |
| Classification | Set, Administration, For Peritoneal Dialysis, Disposable |
| Applicant | PURACATH MEDICAL, INC. 660 4TH STREET #104 San Francisco, CA 94107 |
| Contact | John Ashley |
| Correspondent | John Ashley PURACATH MEDICAL, INC. 660 4TH STREET #104 San Francisco, CA 94107 |
| Product Code | KDJ |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-16 |
| Decision Date | 2016-01-20 |
| Summary: | summary |