QWAClass I

Cardiovascular Delivery Catheter System Positioning And Stabilization Device

21 CFR 870.3955 / Cardiovascular

QWA is the FDA product code for Cardiovascular Delivery Catheter System Positioning And Stabilization Device, a class I device type, regulated under 21 CFR 870.3955. FDA's definition for this code reads: "A cardiovascular delivery catheter system positioning and stabilization device is a platform device or a part of a platform device that aids the positioning and stabilization of delivery catheter systems during cardiovascular interventional procedures (e.g., transcatheter valvular interventions). The device only...". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code: QWA
Device name: Cardiovascular Delivery Catheter System Positioning And Stabilization Device
FDA definition: A cardiovascular delivery catheter system positioning and stabilization device is a platform device or a part of a platform device that aids the positioning and stabilization of delivery catheter systems during cardiovascular interventional procedures (e.g., transcatheter valvular interventions). The device only provides mechanical support and does not include any electrical or robotic components. The device may be for single use or reusable.
Regulation: 21 CFR 870.3955
Device class: Class I
Review panel: Cardiovascular
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
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

Recent clearances

Product code QWA

FDA records hold no clearances under product code QWA.

Recent recalls

Product code QWA

FDA records show no recalls under product code QWA.

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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)