PALINDROME EMERALD 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING

FDA 510(k) clearance K060509 · decided 2006-06-23

Clearance details

K-number: K060509
Device name: PALINDROME EMERALD 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING
Applicant: Tyco Healthcare Group
Decision: Substantially Equivalent
Date received: 2006-02-27
Decision date: 2006-06-23
Days to decision: 116 days
Clearance type: Traditional
Product code: NYU
Device class: 2
Regulation number: 876.5540
Medical specialty: Gastroenterology, Urology
Advisory committee: Gastroenterology, Urology
Location: Mansfield, MA, US
Third-party review: No
Expedited review: No

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Record	Firm	Date
PALINDROME H, SI, HSI CHRONIC CATHETER (K112477)	Covidien	2011-09-28

Record	Firm	Date
PALINDROME EMERALD SPORT PACK Cuffed Dual Lumen Catheter with Pre-curved Shaft and Heparin recall (Z-0408-2009)	Covidien	2008-12-04
PALINDROME EMERALD SPORT PACK Cuffed Dual Lumen Catheter with Pre-curved Shaft and Heparin recall (Z-0409-2009)	Covidien	2008-12-04
PALINDROME EMERALD Kit - Cuffed Dual Lumen Catheter with Pre-curved Shaft and Heparin Coat recall (Z-0410-2009)	Covidien	2008-12-04
PALINDROME EMERALD Kit - Cuffed Dual Lumen Catheter with Pre-cuffed Shaft and Heparin Coat recall (Z-0411-2009)	Covidien	2008-12-04