510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K060509Substantially Equivalent

Palindrome Emerald 14.5 Fr Chronic Hemodialysis Catheter with Heparin Coating

Tyco Healthcare Group LP, Mansfield MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K060509 is the FDA 510(k) clearance record for PALINDROME EMERALD 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING, a class II device, cleared for Tyco Healthcare Group 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 6 510(k) clearances for Tyco Healthcare Group, from to . As of , FDA records show 4 recalls naming K060509.

Clearance record

Decision date
Received
(116 days to decision)
Product code
NYU Catheter, Hemodialysis, Implanted, Coated
Regulation
21 CFR 876.5540
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Tyco Healthcare Group 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