Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name System, Imaging, Optical Coherence Tomography (Oct)
510(k) Number K153479
FOIA Releasable 510(k) K153479
Device Name NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation System
Applicant
Ninepoint Medical, Inc.
12 Oak Park Dr.
Bedford,  MA  01730
Applicant Contact EMAN NAMATI
Correspondent
Ninepoint Medical, Inc.
12 Oak Park Dr.
Bedford,  MA  01730
Correspondent Contact EMAN NAMATI
Regulation Number892.1560
Classification Product Code
NQQ  
Date Received12/02/2015
Decision Date 02/16/2016
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Radiology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-