MWHHumanitarian device exemption

Pulmonic Valved Conduit

Unknown

MWH is the FDA product code for Pulmonic Valved Conduit. As of 2026-09-10, FDA records hold no 510(k) clearances under this code and one recall.

Classification record

Product code: MWH
Device name: Pulmonic Valved Conduit
Device class: Humanitarian device exemption
Review panel: Unknown
Submission type: FDA code 6
Implant: Yes
Life sustaining or supporting: Yes
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

Medtronic Heart Valves Division

Recent clearances

Product code MWH

FDA records hold no clearances under product code MWH.

Recent recalls

Product code MWH

Z-0678-06Unapproved Device-Distribution of an unapproved device into interstate commerce.Shelhigh, Inc. / initiated 2006-01-18 / 25 units

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)