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 Catheter, Percutaneous
510(k) Number K220632
Device Name Boss Crossing Support Catheter
Applicant
Marvao Medical Devices, Ltd.
Unit 1 Galway Business Park, Dangan
Galway,  IE H91A3EF
Applicant Contact Chris Davey
Correspondent
Avania, Ltd.
100 Crowley Dr.
Suite 216
Marlborough,  MA  01752
Correspondent Contact Mary P. LeGraw
Regulation Number870.1250
Classification Product Code
DQY  
Date Received03/04/2022
Decision Date 06/02/2022
Decision Substantially Equivalent (SESE)
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
-
-