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

Single Lumen Ecmo Cannula

21 CFR 870.4100 / Cardiovascular
FDA source (opens on fda.gov)

QHW is the FDA product code for Single Lumen Ecmo Cannula, a class II device type, regulated under 21 CFR 870.4100. FDA's definition for this code reads: "Single-lumen cannulas/catheters to be used with an extracorporeal circuit intended for use in patients with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QHW
Device name
Single Lumen Ecmo Cannula
FDA definition
Single-lumen cannulas/catheters to be used with an extracorporeal circuit intended for use in patients with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent.
Regulation
21 CFR 870.4100
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
3
Ingested recalls
0

Clearances, product code QHW

By decision year
3 clearances under product code QHW with a decision year between 2022 and 2026, 2022 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QHW by decision year
YearClearances
20221
20241
20261

Applicants with the most clearances

Product code QHW
Applicants holding the most 510(k) clearances under product code QHW
ApplicantClearances
Medtronic, Inc.3

Companies listing this code with FDA

Companies whose registered establishments list this code