510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K092597Unknown

Centros Chronic Hemodialysis Catheter Set

Ash Access Technology, Inc., Lafayette IN / Traditional, Unknown
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K092597 is the FDA 510(k) clearance record for CENTROS CHRONIC HEMODIALYSIS CATHETER SET, a class II device, cleared for Ash Access Technology, Inc. on under FDA product code MSD (Catheter, Hemodialysis, Implanted). FDA records list 2 510(k) clearances for Ash Access Technology, Inc., from to . As of , FDA records show no recalls naming K092597.

Clearance record

Decision date
Received
(80 days to decision)
Product code
MSD Catheter, Hemodialysis, Implanted
Regulation
21 CFR 876.5540
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Ash Access Technology, Inc. 3601 Sagamore Pkwy. N., Suite B, Lafayette IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MSD

Trailing 12 months

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

FDA records show no clearances under product code MSD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MSD, 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