K151620 is an FDA 510(k) clearance for the Firefly Peritoneal Dialysis Connector Disinfection System. This device is classified as a Set, Administration, For Peritoneal Dialysis, Disposable (Class II - Special Controls, product code KDJ).
Submitted by Puracath Medical, Inc. (San Francisco, US). The FDA issued a Cleared decision on January 20, 2016, 218 days after receiving the submission on June 16, 2015.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5630.
| 510(k) Number | K151620 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 16, 2015 |
| Decision Date | January 20, 2016 |
| Days to Decision | 218 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KDJ - Set, Administration, For Peritoneal Dialysis, Disposable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5630 |