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510(k) K841791

PLUME FISTULA NEEDLE by Hospal Medical Corp. — Product Code FIQ

K841791 is an FDA 510(k) premarket notification submitted by Hospal Medical Corp. for the device "PLUME FISTULA NEEDLE". The FDA issued a decision of Substantially Equivalent on July 9, 1984. The device falls under product code FIQ (Cannula, A-V Shunt), a Class II device regulated under 21 CFR 876.5540. Hospal Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 1984
Date Received
April 30, 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

Other clearances by Hospal Medical Corp.

  • K893742 — FILTRAL TM 20 HEMODIALYZER/FILTER (July 24, 1989)
  • K884365 — MULTIFLOW(TM) 60 KIT (December 8, 1988)
  • K884326 — FILTRAL TM 8 HEMODIALYZER (December 5, 1988)
  • K883307 — CARDIOFLOW 100 HEMOCONCENTRATOR/PREPARATION KIT (October 12, 1988)
  • K872767 — FILTRAL 10, FILTRAL 12, FILTRAL 16 HEMODIALYZER (December 29, 1987)
  • K871218 — MONITRAL S GS HEMODIALYSIS SINGLE PATIENT UNIT (April 30, 1987)
  • K863961 — HOSPAL BIOSPAL 1800S (December 17, 1986)
  • K863592 — DISSCAP 80E, 110E, 140E, 160E (September 25, 1986)
  • K861156 — HOSPAL DIALYSATE FOR CAVHD (September 23, 1986)
  • K861230 — MONITRAL S (April 25, 1986)

Other clearances for product code FIQ

  • K892887 — ST SERIES SAF-T-SHUNTS ARTERIOVENOUS CANNULA (May 15, 1989)
  • K892663 — S-100 ALLEN-BROWN SHUNT (May 4, 1989)
  • K892666 — SAF-T-SHUNT, S-300 SERIES (May 4, 1989)
  • K844692 — PEDIATRIC SIZED HEMOCATH CATHETER (January 18, 1985)
  • 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)
  • K831801 — HEMOCLAV VENOUS CATHETER (July 7, 1983)

FDA data resources