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, pressure monitoring, cardiac
Definition To measure pressure within the cardiovascular system.
Product CodeOBI
Regulation Number 870.1200
Device Class 2


Premarket Reviews
ManufacturerDecision
ACIST MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 2 2
2021 1 1
2022 11 11
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Defective Device 8 8
Break 3 3
Insufficient Information 2 2
Detachment of Device or Device Component 1 1
Device Damaged by Another Device 1 1
Device Contamination with Chemical or Other Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Respiratory Insufficiency 8 8
No Clinical Signs, Symptoms or Conditions 4 4
No Known Impact Or Consequence To Patient 1 1
Vascular Dissection 1 1
Embolism/Embolus 1 1

-
-