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 Injector And Syringe, Angiographic
510(k) Number K171698
Device Name Smart Syringe
Applicant
Osprey Medical, Inc.
5600 Rowland Road
Suite 250
Minnetonka,  MN  55343
Applicant Contact Melanie Hess
Correspondent
Osprey Medical, Inc.
5600 Rowland Road
Suite 250
Minnetonka,  MN  55343
Correspondent Contact Melanie Hess
Regulation Number870.1650
Classification Product Code
DXT  
Date Received06/08/2017
Decision Date 07/07/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-