PAVHumanitarian device exemption

Catheter, Neuro-Vasculature, Occluding Balloon

21 CFR 882.5150 / Neurology

PAV is the FDA product code for Catheter, Neuro-Vasculature, Occluding Balloon, regulated under 21 CFR 882.5150. FDA's definition for this code reads: "Used to obstruct lower aortic blood flow to augment cerebral perfusion". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and one recall.

Classification record

Product code: PAV
Device name: Catheter, Neuro-Vasculature, Occluding Balloon
FDA definition: Used to obstruct lower aortic blood flow to augment cerebral perfusion.
Regulation: 21 CFR 882.5150
Device class: Humanitarian device exemption
Review panel: Neurology
Submission type: FDA code 6
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 0
Ingested recalls: 1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code PAV.

Recent clearances

Product code PAV

FDA records hold no clearances under product code PAV.

Recent recalls

Product code PAV

Z-0477-2015Class IIAfter aquisition of assets of CoAxia, Zoll discovered that one lot of NeuroFlo Catheters was manufactured by another firm and an...ZOLL Circulation, Inc. / initiated 2014-04-01 / 1 device

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)