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510(k) K051690

VYGON NUTRILINE CATHETERS by Vygon Corp. — Product Code LJS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 2005
Date Received
June 23, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Device Class
Class II
Regulation Number
880.5970
Review Panel
HO
Submission Type

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  • K070705 — MODIFICATION TO: LATEX-FREE BIONECTOR, MODEL# 896.019, 896.039 (November 30, 2007)
  • K061796 — HEPATOSTAT SET, MODEL 760X (November 2, 2006)
  • K061250 — MULTICATH EXPERT (September 29, 2006)
  • K062425 — LIFECATH S PICC AND MIDLINE CATHETER (September 15, 2006)
  • K060944 — NUTRISAFE 2 (September 15, 2006)

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