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510(k) K904433

DUAL LUMEN NEEDLES by Akcess Medical Products, Inc. — Product Code LBW

K904433 is an FDA 510(k) premarket notification submitted by Akcess Medical Products, Inc. for the device "DUAL LUMEN NEEDLES". The FDA issued a decision of Substantially Equivalent on November 23, 1990. The device falls under product code LBW (Set, Dialysis, Single Needle (Co-Axial Flow)), a Class II device regulated under 21 CFR 876.5540. Akcess Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 23, 1990
Date Received
September 28, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Dialysis, Single Needle (Co-Axial Flow)
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 LBW

  • K864629 — MODIFIED DUAL LUMEN NEEDLE (December 16, 1986)
  • K860515 — DUAL LUMEN NEEDLE (PRODUCT CHANGE) (March 4, 1986)
  • K820859 — COAXIAL DUAL FLOW CATHETER (April 16, 1982)
  • K801968 — HEMOCATH I KIDNEY DIALYSIS CATHETER (September 26, 1980)

FDA data resources