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510(k) K840415

HEMOCATH by Quinton, Inc. — Product Code FIQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 1984
Date Received
January 31, 1984
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

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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)
  • 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)
  • K831801 — HEMOCLAV VENOUS CATHETER (July 7, 1983)