The following data is part of a premarket notification filed by Infraredx, Inc. with the FDA for Lipiscan Ivus Imaging System Model Nirs-mc7-70.
Device ID | K093993 |
510k Number | K093993 |
Device Name: | LIPISCAN IVUS IMAGING SYSTEM MODEL NIRS-MC7-70 |
Classification | Catheter, Intravascular, Plaque Morphology Evaluation |
Applicant | Infraredx, Inc. 34 THIRD AVE Burlington, MA 01803 -4414 |
Contact | Steven J Chartier |
Correspondent | Steven J Chartier Infraredx, Inc. 34 THIRD AVE Burlington, MA 01803 -4414 |
Product Code | OGZ |
CFR Regulation Number | 870.1200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-12-24 |
Decision Date | 2010-06-30 |
Summary: | summary |