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 |