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 catheter, intravascular, plaque morphology evaluation
Regulation Description Diagnostic intravascular catheter.
Definition Catheter used for delivery of a sensing modality to a coronary or peripheral artery region for determination of atherosclerotic plaque characteristics. For examination of morphologic features of coronary or peripheral artery lesions or plaques.
Product CodeOGZ
Regulation Number 870.1200
Device Class 2


Premarket Reviews
ManufacturerDecision
INFRAREDX, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2022 1 1
2024 3 3
2025 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Activation, Positioning or Separation Problem 2 2
Difficult to Remove 2 2
Difficult to Advance 1 1
Insufficient Information 1 1
Delivered as Unsterile Product 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Foreign Body In Patient 2 2
Unspecified Vascular Problem 2 2
No Clinical Signs, Symptoms or Conditions 1 1
Insufficient Information 1 1

-
-