The following data is part of a premarket notification filed by Navilyst Medical, Inc. with the FDA for Nmi 2.8 Microcatheter.
| Device ID | K113638 |
| 510k Number | K113638 |
| Device Name: | NMI 2.8 MICROCATHETER |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | NAVILYST MEDICAL, INC. 26 FOREST STREET Marlborough, MA 01752 |
| Contact | Wanda Carpinella |
| Correspondent | Wanda Carpinella NAVILYST MEDICAL, INC. 26 FOREST STREET Marlborough, MA 01752 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-09 |
| Decision Date | 2012-01-05 |
| Summary: | summary |