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 Short-Term Intravascular Filter Catheter
510(k) Number K160747
Device Name Angel Catheter
Applicant
Bio2 Medical, Inc.
4670 Table Mountain Dr.
Golden,  CO  80403
Applicant Contact CHRISTOPHER E. BANAS
Correspondent
Bio2 Medical, Inc.
4670 Table Mountain Dr.
Golden,  CO  80403
Correspondent Contact Julie Ross
Regulation Number870.3375
Classification Product Code
PNS  
Date Received03/18/2016
Decision Date 07/28/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT02186223
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-