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 aspiration thrombectomy catheter
Definition To remove thrombus from the peripheral and/or coronary vasculature through aspiration.
Product CodeQEZ
Regulation Number 870.5150
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ANGIODYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 3
CONTROL MEDICAL TECHNOLOGY
  SUBSTANTIALLY EQUIVALENT 1
KANEKA MEDICAL AMERICA LLC
  SUBSTANTIALLY EQUIVALENT 1
MERIL LIFE SCIENCES PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
VOLCANO ATHEROMED INC.
  SUBSTANTIALLY EQUIVALENT 1
WALK VASCULAR, LLC
  SUBSTANTIALLY EQUIVALENT 4
  1.  K183403  JETi 88 Peripheral Thrombectomy System
  2.  K192439  JETi Peripheral Thrombectomy System
  3.  K201998  JETi AIO Peripheral Thrombectomy System
  4.  K213565  JETi AIO Peripheral Thrombectomy System

MDR Year MDR Reports MDR Events
2021 2 2
2022 18 18
2023 14 14
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 17 17
Detachment of Device or Device Component 3 3
No Apparent Adverse Event 2 2
Difficult to Insert 2 2
Material Separation 2 2
Improper or Incorrect Procedure or Method 1 1
Electro-Static Discharge 1 1
Suction Problem 1 1
Expiration Date Error 1 1
Deformation Due to Compressive Stress 1 1
Contamination /Decontamination Problem 1 1
Loose or Intermittent Connection 1 1
Decrease in Pressure 1 1
Increase in Pressure 1 1
Difficult to Remove 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Device Handling Problem 1 1
Activation Failure 1 1
Material Split, Cut or Torn 1 1
Physical Resistance/Sticking 1 1
Separation Problem 1 1
Difficult to Advance 1 1
Material Twisted/Bent 1 1
Break 1 1
Entrapment of Device 1 1
Power Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 13 13
Hemorrhage/Bleeding 4 4
Cardiac Arrest 3 3
Pulmonary Embolism 2 2
Cardiac Tamponade 2 2
Decreased Respiratory Rate 2 2
Non specific EKG/ECG Changes 2 2
Foreign Body In Patient 2 2
Hematoma 2 2
Embolism/Embolus 2 2
Thrombosis/Thrombus 2 2
Insufficient Information 2 2
Tics/Tremor 1 1
Fever 1 1
Cardiac Perforation 1 1
Diminished Pulse Pressure 1 1
Anemia 1 1
Stroke/CVA 1 1
Low Blood Pressure/ Hypotension 1 1
Infiltration into Tissue 1 1
Perforation of Vessels 1 1

-
-