The following data is part of a premarket notification filed by Navilyst Medical, Inc. with the FDA for Nmi Port, Nmi Port Ii.
| Device ID | K153228 |
| 510k Number | K153228 |
| Device Name: | NMI Port, NMI Port II |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | NAVILYST MEDICAL, INC. 26 FOREST STREET Marlborough, MA 01752 |
| Contact | Robin Fuller |
| Correspondent | Robin Fuller NAVILYST MEDICAL, INC. 26 FOREST STREET Marlborough, MA 01752 |
| Product Code | LJT |
| CFR Regulation Number | 880.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-06 |
| Decision Date | 2015-12-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H965440430 | K153228 | 000 |
| 15051684018784 | K153228 | 000 |
| 15051684018777 | K153228 | 000 |
| 15051684018746 | K153228 | 000 |
| H965440210 | K153228 | 000 |
| H965440200 | K153228 | 000 |
| H965440190 | K153228 | 000 |
| H965440140 | K153228 | 000 |
| H965440130 | K153228 | 000 |
| H965440120 | K153228 | 000 |
| H965440290 | K153228 | 000 |
| 15051684018807 | K153228 | 000 |
| 15051684018890 | K153228 | 000 |
| H965440400 | K153228 | 000 |
| 15051684018876 | K153228 | 000 |
| 15051684018869 | K153228 | 000 |
| 15051684018852 | K153228 | 000 |
| 15051684018845 | K153228 | 000 |
| H965440330 | K153228 | 000 |
| 15051684018821 | K153228 | 000 |
| H965440310 | K153228 | 000 |
| H965440110 | K153228 | 000 |