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, Neurovascular Embolization
510(k) Number K021914
Device Name MICROPLEX COIL SYSTEMS (MCS)
Applicant
MicroVention, Inc.
72 Argonaut
Aliso Viejo,  CA  92656 -1408
Applicant Contact VINCENT CUTARELLI
Correspondent
MicroVention, Inc.
72 Argonaut
Aliso Viejo,  CA  92656 -1408
Correspondent Contact VINCENT CUTARELLI
Regulation Number882.5950
Classification Product Code
HCG  
Date Received06/11/2002
Decision Date 07/09/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-