510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
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K111817Unknown

Palindrome Rt Chronic Catheter

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

K111817 is the FDA 510(k) clearance record for PALINDROME RT CHRONIC CATHETER, a class II device, cleared for Covidien on under FDA product code MSD (Catheter, Hemodialysis, Implanted). FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show 13 recalls naming K111817.

Clearance record

Decision date
Received
(64 days to decision)
Product code
MSD Catheter, Hemodialysis, Implanted
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 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