DeviceClearance

Product code PQK— Cardiovascular

Ellipsys Vascular Access System

Classification name
Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access
Device class
Class 2
Regulation
21 CFR 870.1252
Advisory panel
Cardiovascular
Total cleared
7
First cleared
Most recent

FDA classification definition

“Percutaneous catheter for creation of an arteriovenous fistula for hemodialysis access. This device is a single use percutaneous catheter system that creates an arteriovenous fistula in the arm of patients with chronic kidney disease who need hemodialysis.”

— U.S. Food and Drug Administration, device classification record for product code PQK under 21 CFR 870.1252, via openFDA

Market context for product code PQK

FDA has cleared 7 devices under product code PQK between 2018 and 2019, filed by 4 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PQK

Adverse events under product code PQK

product code PQK
Death
7
Injury
191
Total
198

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code PQK

Data sourced from openFDA. This site is unofficial and independent of the FDA.