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510(k) K790471

JELCO* DISC FILTER-0.2 MICRON by Jelco Laboratories — Product Code FPB

K790471 is an FDA 510(k) premarket notification submitted by Jelco Laboratories for the device "JELCO* DISC FILTER-0.2 MICRON". The FDA issued a decision of Substantially Equivalent on April 30, 1979. The device falls under product code FPB (Filter, Infusion Line), a Class II device regulated under 21 CFR 880.5440. Jelco Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 1979
Date Received
March 5, 1979
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 Jelco Laboratories

  • K791918 — JELCO WINGED INTRAVASCULAR CATHETER (October 2, 1979)
  • K791372 — JELCO & KVO CATHETER PLACEMENT UNIT (September 12, 1979)
  • K790967 — CATHETER METAL HUB/RADIOPAQUE (June 27, 1979)
  • K790968 — CATHETER METAL HUB/NONRADIOPAQUE (June 11, 1979)
  • K790186 — PROTECTIVSTABILIZER (February 26, 1979)
  • K790107 — CATHETER TUBING MODIFICATION (February 1, 1979)
  • K790079 — NEEDLE, BLOOD COLLECTING (February 1, 1979)
  • K781857 — TRAY, ARTERIAL BLOOD GAS SAMPLING (December 11, 1978)
  • K780896 — NEEDLES, DESIGN CHANGE, IV CATHETERS (August 23, 1978)
  • K780519 — FILTER TUBE (May 9, 1978)

Other clearances for product code FPB

  • 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)
  • K941628 — 40 MICRON BLOOD TRANSFUSION FILTER (February 16, 1995)

FDA data resources