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510(k) K133004

VENTED MILLEX -GV, CATHIVEX -GV by Merck Millipore , Ltd. — Product Code BSN

K133004 is an FDA 510(k) premarket notification submitted by Merck Millipore , Ltd. for the device "VENTED MILLEX -GV, CATHIVEX -GV". The FDA issued a decision of Substantially Equivalent on March 27, 2014. The device falls under product code BSN (Filter, Conduction, Anesthetic), a Class II device regulated under 21 CFR 868.5130. Merck Millipore , Ltd. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 2014
Date Received
September 25, 2013
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 Merck Millipore , Ltd.

  • K143583 — Cathivex ¿GV filter units (August 11, 2015)

Other clearances for product code BSN

  • K190663 — Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6 (June 17, 2019)
  • 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)
  • K780519 — FILTER TUBE (May 9, 1978)

FDA data resources