Palindrome Emerald 14.5 FR Chronic Hemodialysis Catheter with Heparin Coating
FDA 510(k) K060509 · Tyco Healthcare Group
510(k) numberK060509
Submission
- Device name
- Palindrome Emerald 14.5 FR Chronic Hemodialysis Catheter with Heparin Coating
- Applicant
- Tyco Healthcare Group
Mansfield, MA, US - Received
- February 27, 2006
- Decision date
- June 23, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NYU – Catheter, Hemodialysis, Implanted, Coated
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5540
- Specialty
- Gastroenterology, Urology
- Implant
- Yes
- Life-sustaining
- Yes
Accessing the central vascular system for long term hemodialysis while reducing infection or thrombogenesis.
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Questions and answers
When was Palindrome Emerald 14.5 FR Chronic Hemodialysis Catheter with Heparin Coating cleared by the FDA?
Palindrome Emerald 14.5 FR Chronic Hemodialysis Catheter with Heparin Coating (K060509) received a 510(k) decision of Substantially Equivalent on June 23, 2006, 116 days after the submission was received.
What is the product code of K060509?
The FDA product code is NYU – Catheter, Hemodialysis, Implanted, Coated, a Class II (moderate risk) device regulated under 21 CFR 876.5540.