510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K181725Substantially Equivalent

Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001 & Catheter & Needle Model No. AMI-6005)

Avenu Medical, Inc., San Juan Capistrano CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K181725 is the FDA 510(k) clearance record for Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001 & Catheter & Needle Model No. AMI-6005), a class II device, cleared for Avenu Medical, Inc. on under FDA product code PQK (Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access). FDA's definition for product code PQK reads: "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...". FDA records list 4 510(k) clearances for Avenu Medical, Inc., from to . As of , FDA records show no recalls naming K181725.

Clearance record

Decision date
Received
(98 days to decision)
Product code
PQK Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access
Regulation
21 CFR 870.1252
Device class
Class II
Review panel
Cardiovascular
Applicant
Avenu Medical, Inc. 27123 Calle Arroyo, Suite 2101, San Juan Capistrano CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PQK

Trailing 12 months

FDA records hold no clearances under product code PQK in the trailing twelve months.

FDA records show no clearances under product code PQK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PQK, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260