The following data is part of a premarket notification filed by Navilyst Medical, Inc. with the FDA for Nmi Fc.
| Device ID | K091634 |
| 510k Number | K091634 |
| Device Name: | NMI FC |
| Classification | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass |
| Applicant | NAVILYST MEDICAL, INC. 26 FOREST STREET Marlborough, MA 01752 |
| Contact | Shilpa Prem |
| Correspondent | Shilpa Prem NAVILYST MEDICAL, INC. 26 FOREST STREET Marlborough, MA 01752 |
| Product Code | DTL |
| CFR Regulation Number | 870.4290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-04 |
| Decision Date | 2010-03-01 |
| Summary: | summary |