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 Valvulotome
510(k) Number K221902
Device Name LimFlow Vector
Applicant
LimFlow, Inc.
3031 Tisch Way - 110 Plz. W.
San Jose,  CA  95128
Applicant Contact Zachary Woodson
Correspondent
LimFlow, Inc.
3031 Tisch Way - 110 Plz. W.
San Jose,  CA  95128
Correspondent Contact Zachary Woodson
Regulation Number870.4885
Classification Product Code
MGZ  
Date Received06/30/2022
Decision Date 12/21/2022
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
Recalls CDRH Recalls
-
-