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510(k) K780519

FILTER TUBE by Jelco Laboratories — Product Code BSN

K780519 is an FDA 510(k) premarket notification submitted by Jelco Laboratories for the device "FILTER TUBE". The FDA issued a decision of Substantially Equivalent on May 9, 1978. The device falls under product code BSN (Filter, Conduction, Anesthetic), a Class II device regulated under 21 CFR 868.5130. Jelco Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 1978
Date Received
March 31, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filter, Conduction, Anesthetic
Device Class
Class II
Regulation Number
868.5130
Review Panel
AN
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)
  • K790471 — JELCO* DISC FILTER-0.2 MICRON (April 30, 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)

Other clearances for product code BSN

  • K190663 — Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6 (June 17, 2019)
  • K133004 — VENTED MILLEX -GV, CATHIVEX -GV (March 27, 2014)
  • K083451 — PORTEX EPIDURAL FILTER, MODEL 100/386/010, VARIOUS STANDARD AND CUSTOM TRAYS (March 4, 2009)
  • K023892 — MILLEX VV, GV, AND HV SYRINGE FILTER UNITS (January 17, 2003)
  • K013988 — MILLEX GP STERILIZING FILTER UNIT, MODEL SLGP 033 R (April 4, 2002)
  • K963717 — MILLEX - MP FILTER UNIT (SLMPO25SS/SLMPL25SS) (June 10, 1997)
  • K960928 — SYRINGEFILTER (April 4, 1997)
  • K902666 — ANESTHESIA CONDUCTION FILTER (April 23, 1991)

FDA data resources