510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QFJClass II

Intravascular Bleed Monitor

21 CFR 870.1345 / Cardiovascular
FDA source (opens on fda.gov)

QFJ is the FDA product code for Intravascular Bleed Monitor, a class II device type, regulated under 21 CFR 870.1345. FDA's definition for this code reads: "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". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
QFJ
Device name
Intravascular Bleed Monitor
FDA 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.
Regulation
21 CFR 870.1345
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
1

Clearances, product code QFJ

By decision year
2 clearances under product code QFJ with a decision year between 2019 and 2023, 2019 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QFJ by decision year
YearClearances
20191
20231

Applicants with the most clearances

Product code QFJ
Applicants holding the most 510(k) clearances under product code QFJ
ApplicantClearances
Saranas, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code QFJ.