QZVClass III

Pediatric Extracorporeal Synthetic Semipermeable Membrane Cartridge For Acute Kidney Injury

Unknown

QZV is the FDA product code for Pediatric Extracorporeal Synthetic Semipermeable Membrane Cartridge For Acute Kidney Injury, a class III device type. FDA's definition for this code reads: "For the treatment of acute kidney injury in pediatric patients, in conjunction with continuous kidney replacement treatment (CKRT)". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code: QZV
Device name: Pediatric Extracorporeal Synthetic Semipermeable Membrane Cartridge For Acute Kidney Injury
FDA definition: For the treatment of acute kidney injury in pediatric patients, in conjunction with continuous kidney replacement treatment (CKRT).
Device class: Class III
Review panel: Unknown
Submission type: FDA code 6
Implant: No
Life sustaining or supporting: Yes
GMP exempt: No
Third party review eligible: No
Ingested clearances: 0
Ingested recalls: 0

Companies listing this code with FDA

Companies whose registered establishments list this code

Seastar Medical, Inc.

Recent clearances

Product code QZV

FDA records hold no clearances under product code QZV.

Recent recalls

Product code QZV

FDA records show no recalls under product code QZV.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)