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 Vessel Guard Or Cover
510(k) Number K100984
Device Name XYLOS VESSEL GUARD
Applicant
Xylos Corporation
838 Town Center Dr.
Langhorne,  PA  19047
Applicant Contact JOYCE ELKINS
Correspondent
Xylos Corporation
838 Town Center Dr.
Langhorne,  PA  19047
Correspondent Contact JOYCE ELKINS
Regulation Number870.3470
Classification Product Code
OMR  
Date Received04/08/2010
Decision Date 07/07/2010
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-