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510(k) K893679

SHUNT CONNECTORS by Akcess Medical Products, Inc. — Product Code FJQ

K893679 is an FDA 510(k) premarket notification submitted by Akcess Medical Products, Inc. for the device "SHUNT CONNECTORS". The FDA issued a decision of Substantially Equivalent on July 24, 1989. The device falls under product code FJQ (Connector, Shunt), a Class I 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
July 24, 1989
Date Received
May 16, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Connector, Shunt
Device Class
Class I
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 FJQ

  • K771422 — PATIENT BY-PASS (January 3, 1978)
  • K771429 — DISP. TEFLON CONNHCTOR (December 22, 1977)

FDA data resources