The following data is part of a premarket notification filed by Navilyst Medical, Inc. with the FDA for Nmi Coaxial Microintroducer Set.
| Device ID | K132713 |
| 510k Number | K132713 |
| Device Name: | NMI COAXIAL MICROINTRODUCER SET |
| Classification | Dilator, Vessel, For Percutaneous Catheterization |
| Applicant | NAVILYST MEDICAL, INC. 26 FOREST STREET Marlborough, MA 01752 |
| Contact | Michael P Hanley |
| Correspondent | Michael P Hanley NAVILYST MEDICAL, INC. 26 FOREST STREET Marlborough, MA 01752 |
| Product Code | DRE |
| CFR Regulation Number | 870.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-30 |
| Decision Date | 2013-09-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H965457861 | K132713 | 000 |
| H965457651 | K132713 | 000 |
| H965457641 | K132713 | 000 |
| H965457631 | K132713 | 000 |
| H965457621 | K132713 | 000 |
| H965457611 | K132713 | 000 |
| H965457601 | K132713 | 000 |
| H965457591 | K132713 | 000 |
| H965457581 | K132713 | 000 |
| H965457571 | K132713 | 000 |
| H965457561 | K132713 | 000 |
| H965457551 | K132713 | 000 |
| H965457541 | K132713 | 000 |
| H965457531 | K132713 | 000 |
| H965457521 | K132713 | 000 |
| H965457511 | K132713 | 000 |
| H965457501 | K132713 | 000 |
| H965457491 | K132713 | 000 |
| H965457661 | K132713 | 000 |
| H965457671 | K132713 | 000 |
| H965457851 | K132713 | 000 |
| H965457841 | K132713 | 000 |
| H965457831 | K132713 | 000 |
| H965457821 | K132713 | 000 |
| H965457811 | K132713 | 000 |
| H965457791 | K132713 | 000 |
| H965457781 | K132713 | 000 |
| H965457771 | K132713 | 000 |
| H965457761 | K132713 | 000 |
| H965457751 | K132713 | 000 |
| H965457741 | K132713 | 000 |
| H965457731 | K132713 | 000 |
| H965457721 | K132713 | 000 |
| H965457711 | K132713 | 000 |
| H965457701 | K132713 | 000 |
| H965457691 | K132713 | 000 |
| H965457681 | K132713 | 000 |
| H965457481 | K132713 | 000 |