PALINDROME EMERALD 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING— 510(k) K060509

Name: FDA 510(k) clearance K060509
Creator: U.S. Food and Drug Administration
Published: 2006-06-23

Substantially Equivalent

Tyco Healthcare Group

FDA 510(k) clearance K060509 for PALINDROME EMERALD 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING, Substantially Equivalent on 2006-06-23. Applicant: Tyco Healthcare Group. Device class: 2.

Clearance details

Applicant: Tyco Healthcare Group
Product code: Code NYU
Device class: Class 2
Regulation: 21 CFR 876.5540
Advisory panel: Gastroenterology, Urology
Date received: 2006-02-27
Decision date: 2006-06-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mansfield, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NYU

view all

K112477 — PALINDROME H, SI, HSI CHRONIC CATHETER2011-09-28

More clearances from Tyco Healthcare Group

view all

K063536 — POLYSORB* SYNTHETIC ABSORBABLE SUTURE WITH MODIFIED PACKAGING2007-01-29

Data sourced from openFDA. This site is unofficial and independent of the FDA.