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 stripper, vein, external
Regulation Description External vein stripper.
Product CodeDWQ
Regulation Number 870.4885
Device Class 2


Premarket Reviews
ManufacturerDecision
LEMAITRE VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 29 29
2020 5 5
2023 1 1
2024 4 4
2025 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Conduct 11 11
Device Contamination with Body Fluid 7 7
Electrical /Electronic Property Problem 7 7
No Device Output 3 3
Material Split, Cut or Torn 2 2
Intermittent Loss of Power 2 2
Failure to Read Input Signal 1 1
Unintended Movement 1 1
Defective Component 1 1
Defective Device 1 1
Therapeutic or Diagnostic Output Failure 1 1
Failure to Power Up 1 1
Mechanics Altered 1 1
Power Problem 1 1
Appropriate Term/Code Not Available 1 1
Connection Problem 1 1
Overheating of Device 1 1
Loose or Intermittent Connection 1 1
Loss of Power 1 1
Mechanical Jam 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 23 23
No Clinical Signs, Symptoms or Conditions 10 10
No Patient Involvement 5 5
No Information 4 4
No Consequences Or Impact To Patient 2 2

-
-