PKKNot classified

Stent Delivery System

Unknown

PKK is the FDA product code for Stent Delivery System. FDA's definition for this code reads: "For coarctation of the aorta". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code: PKK
Device name: Stent Delivery System
FDA definition: For coarctation of the aorta
Device class: Not classified
Review panel: Unknown
Submission type: Contact ODE
Implant: Yes
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

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

Recent clearances

Product code PKK

FDA records hold no clearances under product code PKK.

Recent recalls

Product code PKK

FDA records show no recalls under product code PKK.

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)