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

TPLC - Total Product Life Cycle
  • 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 show TPLC since Back to Search Results
Device valvulotome
Regulation Description External vein stripper.
Product CodeMGZ
Regulation Number 870.4885
Device Class 2


Premarket Reviews
ManufacturerDecision
AVEERA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
LIMFLOW, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 6 6
2021 2 2
2022 13 13
2023 23 23
2024 3 3
2025 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Retraction Problem 22 22
Adverse Event Without Identified Device or Use Problem 9 9
Difficult to Open or Close 8 8
Material Perforation 3 3
Material Twisted/Bent 2 2
Material Deformation 2 2
Connection Problem 2 2
Leak/Splash 1 1
Break 1 1
Device Markings/Labelling Problem 1 1
Difficult to Flush 1 1
Defective Component 1 1
Positioning Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Flare or Flash 1 1
Mechanics Altered 1 1
Sharp Edges 1 1
Material Separation 1 1
Detachment of Device or Device Component 1 1
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 26 26
Perforation of Vessels 16 16
No Known Impact Or Consequence To Patient 5 5
Insufficient Information 4 4
Vascular Dissection 1 1
Laceration(s) 1 1
No Consequences Or Impact To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 LeMaitre Vascular, Inc. II Aug-28-2023
-
-