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510(k) K023892

MILLEX VV, GV, AND HV SYRINGE FILTER UNITS by Millipore Corp. — Product Code BSN

K023892 is an FDA 510(k) premarket notification submitted by Millipore Corp. for the device "MILLEX VV, GV, AND HV SYRINGE FILTER UNITS". The FDA issued a decision of Substantially Equivalent on January 17, 2003. The device falls under product code BSN (Filter, Conduction, Anesthetic), a Class II device regulated under 21 CFR 868.5130. Millipore Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 2003
Date Received
November 22, 2002
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 Millipore Corp.

  • K013988 — MILLEX GP STERILIZING FILTER UNIT, MODEL SLGP 033 R (April 4, 2002)
  • K963717 — MILLEX - MP FILTER UNIT (SLMPO25SS/SLMPL25SS) (June 10, 1997)
  • K941326 — ULTRAFREE-CL (May 27, 1994)
  • K934069 — MILLEX, DUALEX (PLUS, ULTRA) (April 21, 1994)
  • K924347 — WATERS(TM) 996 PDA (December 11, 1992)
  • K922388 — WATERS(TM) LC MODULE I FOR CLINICAL USE (September 11, 1992)
  • K920136 — WATERS 717 AUTOSAMPLER (February 19, 1992)
  • K914841 — CHROMATOGRAPHY CLINICAL USE 75JQR (December 10, 1991)
  • K903647 — MODULE 486 VARIABLE WAVELENGTH TUNABLE UV/VIS DETE (September 11, 1990)
  • K872792 — WATERS M600E MULTI-SOLVENT DELIVERY SYSTEM (July 31, 1987)

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)
  • 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)
  • K780519 — FILTER TUBE (May 9, 1978)

FDA data resources