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 |