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510(k) K963717

MILLEX - MP FILTER UNIT (SLMPO25SS/SLMPL25SS) by Millipore Corp. — Product Code BSN

K963717 is an FDA 510(k) premarket notification submitted by Millipore Corp. for the device "MILLEX - MP FILTER UNIT (SLMPO25SS/SLMPL25SS)". The FDA issued a decision of Substantially Equivalent on June 10, 1997. 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
June 10, 1997
Date Received
September 16, 1996
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.

  • 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)
  • 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)
  • 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)
  • K960928 — SYRINGEFILTER (April 4, 1997)
  • K902666 — ANESTHESIA CONDUCTION FILTER (April 23, 1991)
  • K780519 — FILTER TUBE (May 9, 1978)

FDA data resources