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 Device, Vascular, For Promoting Embolization
510(k) Number K220699
Device Name Prestige Coil System
Applicant
Bait USA, LLC
29, Parker
Irvine,  CA  92618
Applicant Contact Michael Peters
Correspondent
Bait USA, LLC
29, Parker
Irvine,  CA  92618
Correspondent Contact Michael Peters
Regulation Number870.3300
Classification Product Code
KRD  
Date Received03/10/2022
Decision Date 04/08/2022
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
Recalls CDRH Recalls
-
-