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510(k) K844433

VACCESS 2000 SINGLE LUMEN SUBCLAVIAN CANNULA by Vas-Cath of Canada , Ltd. — Product Code LFJ

K844433 is an FDA 510(k) premarket notification submitted by Vas-Cath of Canada , Ltd. for the device "VACCESS 2000 SINGLE LUMEN SUBCLAVIAN CANNULA". The FDA issued a decision of Substantially Equivalent on March 13, 1985. The device falls under product code LFJ (Catheter, Subclavian), a Class II device regulated under 21 CFR 876.5540. Vas-Cath of Canada , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 1985
Date Received
November 16, 1984
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 Vas-Cath of Canada , Ltd.

  • K875188 — LUER LOCK CONNECTORS / RIDIG P.V.C. (March 2, 1988)
  • K871817 — VAS-CATH PERITONEAL DIALYSIS CATHETER (July 16, 1987)
  • K871487 — VAS-CATH PERMANENT SINGLE LUMEN HEMODIALYSIS CATH (June 12, 1987)
  • K871488 — VAS-CATH PERMANENT DUAL LUMEN HEMODIALYSIS CATH (June 12, 1987)
  • K863982 — VAS-CATH PERICARDIOCENTESIS CATHETER, SET & TRAY (October 24, 1986)
  • K853283 — VACCESS TM 4006 (August 22, 1985)
  • K844854 — OPTI-FLOW DIGITAL SUBTRACTION ANGIOGRAPHY CAT-KIT (May 21, 1985)
  • K844800 — OPTI-FLOW & OPTI-TORQUE ANGIOGRAPHIC CATHETERS (May 16, 1985)
  • K850009 — EVANS, VAS-CATH EPIDURAL NEEDLE & CATHETER (May 13, 1985)
  • K844434 — VACCESS 3000 SINGLE LUMEN JUGULAR CANNULA-CATH (March 13, 1985)

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