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510(k) K801602

DESERET I.V. FILTER by Hospital Products Co. — Product Code FPB

K801602 is an FDA 510(k) premarket notification submitted by Hospital Products Co. for the device "DESERET I.V. FILTER". The FDA issued a decision of Substantially Equivalent on August 27, 1980. The device falls under product code FPB (Filter, Infusion Line), a Class II device regulated under 21 CFR 880.5440. Hospital Products Co. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 1980
Date Received
July 14, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filter, Infusion Line
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

Other clearances by Hospital Products Co.

  • K823696 — MICRO Z BLOOD COLLECTING NEEDLES (January 26, 1983)
  • K810318 — PARKE-DAVIS NON-WOVEN SPONGE (February 26, 1981)
  • K801173 — ANGIO-FLO MONITORING KIT (May 28, 1980)
  • K792386 — NUTRA-PH INSTRUMENT MILK (December 10, 1979)
  • K791350 — POPE AMBULATORY HALO VEST (August 3, 1979)

Other clearances for product code FPB

  • K261403 — Lipipor NLF1A Infusion Filter, Lipipor NLF2A & NLF2NTA Infusion Filters, Lipipor (August 31, 2026)
  • K233277 — Filter Needle for Single Use (May 10, 2024)
  • K143583 — Cathivex ¿GV filter units (August 11, 2015)
  • K113227 — NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER (December 8, 2011)
  • K021293 — ARTERIA BLOOD FILTER (August 22, 2002)
  • K993379 — PALL SUPOR AEF FILTER (December 16, 1999)
  • K974661 — 0.2 U BACTERIAL FILTER (February 11, 1998)
  • K964283 — AUTOPRIME (January 22, 1997)
  • K954331 — PALL LEA FILTER (LIPID EMULSION FILTER) (I.V. FILTER) (January 9, 1997)
  • K933523 — I.V. FILTER SET (May 19, 1995)

FDA data resources