510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K112477Unknown

Palindrome H, Si, Hsi Chronic Catheter

Medtronic, Inc., Mansfield MA / Special, Unknown
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K112477 is the FDA 510(k) clearance record for PALINDROME H, SI, HSI CHRONIC CATHETER, a class II device, cleared for Covidien on under FDA product code NYU (Catheter, Hemodialysis, Implanted, Coated). FDA's definition for product code NYU reads: "Accessing the central vascular system for long term hemodialysis while reducing infection or thrombogenesis". FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show 65 recalls naming K112477.

Clearance record

Decision date
Received
(30 days to decision)
Product code
NYU Catheter, Hemodialysis, Implanted, Coated
Regulation
21 CFR 876.5540
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Covidien 15 Hampshire St., Mansfield MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NYU

Trailing 12 months

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

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