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

Tubing, Long Term Support Greater Than 6 Hours

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

QWF is the FDA product code for Tubing, Long Term Support Greater Than 6 Hours, a class II device type, regulated under 21 CFR 870.4100. FDA's definition for this code reads: "The tubing and accessories are intended to connect perfusion devices and circulate blood as part of extracorporeal membrane oxygenation lasting longer than 6 hours". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
QWF
Device name
Tubing, Long Term Support Greater Than 6 Hours
FDA definition
The tubing and accessories are intended to connect perfusion devices and circulate blood as part of extracorporeal membrane oxygenation lasting longer than 6 hours.
Regulation
21 CFR 870.4100
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
No
Life sustaining or supporting
Yes
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code QWF

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

Applicants with the most clearances

Product code QWF
Applicants holding the most 510(k) clearances under product code QWF
ApplicantClearances
Medtronic, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code