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510(k) K072255

MINRAD INC. NASAL SCAVENGING CIRCUIT by Minrad, Inc. — Product Code CBN

K072255 is an FDA 510(k) premarket notification submitted by Minrad, Inc. for the device "MINRAD INC. NASAL SCAVENGING CIRCUIT". The FDA issued a decision of Substantially Equivalent on October 18, 2007. The device falls under product code CBN (Apparatus, Gas-Scavenging), a Class II device regulated under 21 CFR 868.5430. Minrad, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 2007
Date Received
August 13, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Gas-Scavenging
Device Class
Class II
Regulation Number
868.5430
Review Panel
AN
Submission Type

Other clearances by Minrad, Inc.

  • K071814 — LIGHT SABRE SPINAL ACCESS DEVICE (October 16, 2007)
  • K062231 — MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, STANDARD, MODEL 310001 (August 31, 2006)
  • K062230 — MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, SHORT, MODEL 310002 (August 31, 2006)
  • K041852 — MR TESTED FIBER OPTIC SHORT LARYNGOSCOPE HANDLE, MODEL 310002 (November 15, 2004)
  • K041846 — SABRESOURCE DRAPE (August 26, 2004)
  • K021084 — LIGHT SABER SPINAL NEEDLE (July 3, 2002)
  • K013040 — LIGHT SABER INTRODUCER NEEDLE (December 7, 2001)
  • K982735 — LIGHT SABER BONE BIOPSY NEEDLE (September 9, 1998)
  • K982018 — LIGHT SABER ASPIRATION NEEDLE (August 7, 1998)
  • K981796 — LIGHT SABER CORE TISSUE NEEDLE (August 5, 1998)

Other clearances for product code CBN

  • K223452 — Nitronox Scavenger Plus (March 5, 2023)
  • K193646 — Dynamic Gas Scavenging System 2 (DGSS - 2) (December 4, 2020)
  • K160950 — MINISCAV (May 5, 2017)
  • K142138 — ISO-GARD MASK (October 30, 2014)
  • K132729 — ISO-GARD MASK (January 9, 2014)
  • K123176 — ISO-GARD CLEARAIR MASK (February 14, 2013)
  • K110930 — ACTIVE WASTE GAS SCAVENGER (June 23, 2011)
  • K092031 — VAPOR-CLEAR, MODEL 100 (April 16, 2010)
  • K080039 — PASSIVE WASTE GAS SCAVENGER, MODEL 14600 (April 14, 2008)
  • K063519 — DYNAMIC GAS SCAVENGING SYSTEM (DGSS) (December 1, 2006)

FDA data resources