The following data is part of a premarket notification filed by Navilyst Medical, Inc. with the FDA for Nmi Dialysis Catheter.
| Device ID | K131260 |
| 510k Number | K131260 |
| Device Name: | NMI DIALYSIS CATHETER |
| Classification | Catheter, Hemodialysis, Implanted |
| Applicant | NAVILYST MEDICAL, INC. 26 FOREST STREET Marlborough, MA 01752 |
| Contact | Lorraine M Hanley |
| Correspondent | Lorraine M Hanley NAVILYST MEDICAL, INC. 26 FOREST STREET Marlborough, MA 01752 |
| Product Code | MSD |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-02 |
| Decision Date | 2014-02-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884450793296 | K131260 | 000 |
| 10884450786311 | K131260 | 000 |
| 10884450786328 | K131260 | 000 |
| 10884450793838 | K131260 | 000 |
| 10884450793289 | K131260 | 000 |
| 10884450793753 | K131260 | 000 |
| 10884450793319 | K131260 | 000 |
| 10884450793975 | K131260 | 000 |
| 10884450793234 | K131260 | 000 |