The following data is part of a premarket notification filed by Phase One Medical with the FDA for Symetrex Long Term Hemodialysis Catheter.
| Device ID | K140884 |
| 510k Number | K140884 |
| Device Name: | SYMETREX LONG TERM HEMODIALYSIS CATHETER |
| Classification | Catheter, Hemodialysis, Implanted |
| Applicant | PHASE ONE MEDICAL 55 NORTHERN BLVD SUITE 200 Great Neck, NY 11021 |
| Contact | Aditya Sukthankar |
| Correspondent | Aditya Sukthankar PHASE ONE MEDICAL 55 NORTHERN BLVD SUITE 200 Great Neck, NY 11021 |
| Product Code | MSD |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-07 |
| Decision Date | 2014-11-26 |
| Summary: | summary |