Home / 510(k) Clearances / K891754

510(k) K891754

DC-4 SHUNT INFUSION T by Akcess Medical Products, Inc. — Product Code FKB

K891754 is an FDA 510(k) premarket notification submitted by Akcess Medical Products, Inc. for the device "DC-4 SHUNT INFUSION T". The FDA issued a decision of Substantially Equivalent on April 7, 1989. The device falls under product code FKB (Connector, Blood Tubing, Infusion T), a Class II device regulated under 21 CFR 876.5820. Akcess Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 7, 1989
Date Received
March 23, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Connector, Blood Tubing, Infusion T
Device Class
Class II
Regulation Number
876.5820
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 FKB

  • K771426 — PEDIATRIC INFUSION T (December 20, 1977)

FDA data resources