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510(k) K831401

SINGLE NEEDLE SUBCLAVIAN VEIN ACCESS by Med-West, Inc. — Product Code FIQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 1983
Date Received
May 2, 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 Med-West, Inc.

  • K880877 — CONTRAST INJECTION DEVICE (May 31, 1988)
  • K880398 — POWER TOILET ELEVATOR (March 17, 1988)
  • K874470 — MWI 400 WOUND DRESSING (December 18, 1987)
  • K872724 — SHEATH/DILATORS (September 15, 1987)
  • K854612 — ACUTE HEMODIALYSIS TRAY, CAT.#09-9540-7 (January 3, 1986)
  • K852162 — MNI 400 INJECTION CAPS (June 12, 1985)
  • K842342 — MWI 888 & 666 DOUBLE LUMEN SUBCLAVIAN (June 14, 1984)
  • K832124 — CPC, COUBLE LUMEN CARDIOPLEGIA-AIR ASPI (August 12, 1983)
  • K831828 — TEFLON FEMORAL CATHETER MWI 100,10 & (July 7, 1983)
  • K831440 — SINGLE NEEDLE SUBCLAVIAN VEIN MWI250/260 (June 3, 1983)

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)