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510(k) K896568

DUALYSE-CATH - CODES #1132.212, 1132.112 by Vygon Corp. — Product Code LFJ

K896568 is an FDA 510(k) premarket notification submitted by Vygon Corp. for the device "DUALYSE-CATH - CODES #1132.212, 1132.112". The FDA issued a decision of Substantially Equivalent on May 9, 1990. The device falls under product code LFJ (Catheter, Subclavian), a Class II device regulated under 21 CFR 876.5540. Vygon Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 1990
Date Received
November 20, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Subclavian
Device Class
Class II
Regulation Number
876.5540
Review Panel
GU
Submission Type

Other clearances by Vygon Corp.

  • K151237 — Nutrisafe 2- ENFit Adaptor (February 9, 2016)
  • K141026 — LEADERFLEX (July 30, 2014)
  • K121105 — NUTRISAFE 2 FEEDING TUBE (December 18, 2012)
  • K100163 — NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXX (October 13, 2011)
  • K073493 — HEPATOSTAT SET (May 6, 2008)
  • 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)

Other clearances for product code LFJ

  • K920780 — MEDSURG INSERTION TRAY (August 19, 1994)
  • K925819 — AKCESS0CATH KIT (August 2, 1994)
  • K925818 — AKCESS-CATH (April 5, 1994)
  • K913468 — ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET/TRAY (March 24, 1994)
  • K931120 — COAXIAL ACUTE CATHETER (January 14, 1994)
  • K920634 — SPLITTABLE SHEATH INTRODUCER SET (January 14, 1994)
  • K914162 — VAS-CATH FLEXXICON 2 DUAL LUMEN DIALYSIS CATHETERS (July 1, 1993)
  • K915423 — HEMO-CATH SILICONE ACCESS CATHETER (February 2, 1993)
  • K914826 — AKCESS-CATH KIT (April 10, 1992)
  • K910501 — PERMANENT SILICONE CATHETERS (April 29, 1991)

FDA data resources