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510(k) K900803

DUAL LUMEN SUB-CLAVIAN CATHETERS DLSC 600S & 800S by Akcess Medical Products, Inc. — Product Code LFJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 1990
Date Received
February 20, 1990
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 Akcess Medical Products, Inc.

  • K926374 — SILICONE CATHETER REPAIR KITS (October 7, 1994)
  • K925819 — AKCESS0CATH KIT (August 2, 1994)
  • K925818 — AKCESS-CATH (April 5, 1994)
  • K930630 — RIGHT ATRIAL CATHETER (February 7, 1994)
  • K920634 — SPLITTABLE SHEATH INTRODUCER SET (January 14, 1994)
  • K931120 — COAXIAL ACUTE CATHETER (January 14, 1994)
  • K914936 — CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATH SET (April 23, 1992)
  • K920331 — RIGHT ATRIAL CATHETER KITS (April 22, 1992)
  • K914826 — AKCESS-CATH KIT (April 10, 1992)
  • K915215 — CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATH. KITS (March 27, 1992)

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)
  • K920634 — SPLITTABLE SHEATH INTRODUCER SET (January 14, 1994)
  • K931120 — COAXIAL ACUTE CATHETER (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)