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 intravascular bleed monitor
Definition An intravascular bleed monitor is a probe, catheter, or catheter introducer that measures changes in bioimpedance and uses an algorithm to detect or monitor progression of potential internal bleeding complications.
Product CodeQFJ
Regulation Number 870.1345
Device Class 2


Premarket Reviews
ManufacturerDecision
SARANAS INC.
  SUBSTANTIALLY EQUIVALENT 1
SARANAS, INC.
  GRANTED 1

MDR Year MDR Reports MDR Events
2023 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Improper or Incorrect Procedure or Method 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
Low Blood Pressure/ Hypotension 2 2
Perforation of Vessels 1 1
Hematoma 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Saranas, Inc. II Sep-07-2022
-
-