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510(k) K060509

PALINDROME EMERALD 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING by Tyco Healthcare Group — Product Code NYU

K060509 is an FDA 510(k) premarket notification submitted by Tyco Healthcare Group for the device "PALINDROME EMERALD 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING". The FDA issued a decision of Substantially Equivalent on June 23, 2006. The device falls under product code NYU (Catheter, Hemodialysis, Implanted, Coated), a Class II device regulated under 21 CFR 876.5540. Tyco Healthcare Group has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 2006
Date Received
February 27, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Hemodialysis, Implanted, Coated
Device Class
Class II
Regulation Number
876.5540
Review Panel
GU
Submission Type

Accessing the central vascular system for long term hemodialysis while reducing infection or thrombogenesis.

Other clearances by Tyco Healthcare Group

  • K080898 — AUTO SUTURE ENDO GIA STAPLERS WITH ENDO GIA SINGLE USE LOADING UNITS WITH STAPLE (May 5, 2008)
  • K071371 — COPA AMD ANTIMICROBIAL WOUND DRESSING (November 19, 2007)
  • K063536 — POLYSORB* SYNTHETIC ABSORBABLE SUTURE WITH MODIFIED PACKAGING (January 29, 2007)
  • K060649 — GENIUS 2 INFRARED TYMPANIC ELECTRONIC THERMOMETER, MODEL 303000 (May 22, 2006)
  • K010909 — NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE (April 9, 2001)

Other clearances for product code NYU

  • K112477 — PALINDROME H, SI, HSI CHRONIC CATHETER (September 28, 2011)

FDA data resources