Home / 510(k) Clearances / K831801

510(k) K831801

HEMOCLAV VENOUS CATHETER by Exo, Inc. — Product Code FIQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 7, 1983
Date Received
June 3, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cannula, A-V Shunt
Device Class
Class II
Regulation Number
876.5540
Review Panel
GU
Submission Type

Other clearances by Exo, Inc.

  • K243239 — Lung AI (LAI001) (April 24, 2025)
  • K242359 — Strain AI (SAI001) (November 20, 2024)
  • K232501 — AI Platform (AIP001) (November 17, 2023)
  • K230497 — Bladder AI (AIBV01) (June 22, 2023)

Other clearances for product code FIQ

  • K892887 — ST SERIES SAF-T-SHUNTS ARTERIOVENOUS CANNULA (May 15, 1989)
  • K892666 — SAF-T-SHUNT, S-300 SERIES (May 4, 1989)
  • K892663 — S-100 ALLEN-BROWN SHUNT (May 4, 1989)
  • K844692 — PEDIATRIC SIZED HEMOCATH CATHETER (January 18, 1985)
  • K841791 — PLUME FISTULA NEEDLE (July 9, 1984)
  • K840322 — HEMOFILTRATION CATHETER HF-100 (April 24, 1984)
  • K840415 — HEMOCATH (April 20, 1984)
  • K834358 — PARALLEL DUAL LUMEN SUBCLAVIAN CANNULA (April 2, 1984)
  • K840436 — HEMASITE/RENALOY -VASCULAR ACCESS SHUNT (February 21, 1984)
  • K833622 — RENALLOY HEMASITE VASCULAR ACCESS SHUNT (November 29, 1983)