510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
QNRClass II

Blood Pump For Ecmo, Long-Term (> 6 Hours) Use

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

QNR is the FDA product code for Blood Pump For Ecmo, Long-Term (> 6 Hours) Use, a class II device type, regulated under 21 CFR 870.4100. FDA's definition for this code reads: "A blood pump for long-term circulatory support is a device intended for use as part of an extracorporeal circuit intended to provide assisted extracorporeal circulation and physiologic gas exchange of the patient's blood in patients with acute respiratory failure or acute cardiopulmonary failure where other available...". As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
QNR
Device name
Blood Pump For Ecmo, Long-Term (> 6 Hours) Use
FDA definition
A blood pump for long-term circulatory support is a device intended for use as part of an extracorporeal circuit intended to provide assisted extracorporeal circulation and physiologic gas exchange of the patient's blood 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
Yes
GMP exempt
No
Third party review eligible
No
Ingested clearances
8
Ingested recalls
2

Clearances, product code QNR

By decision year
8 clearances under product code QNR with a decision year between 2021 and 2025, 2022 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code QNR by decision year
YearClearances
20211
20222
20232
20242
20251

Applicants with the most clearances

Product code QNR
Applicants holding the most 510(k) clearances under product code QNR
ApplicantClearances
Cardiacassist, Inc.3
Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.)2
Abbott Medical1
Abbott (Formerly Thoratec Corporation)1
Medtronic, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code