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510(k) K131912

CONCHATHERM NEPTUNE HEATED HUMIDIFIER, COMFORT FLO HUMIDIFICATION SYSTEM, CONCHASMART COLUMN by Teleflex, Inc. — Product Code BTT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 2014
Date Received
June 26, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Humidifier, Respiratory Gas, (Direct Patient Interface)
Device Class
Class II
Regulation Number
868.5450
Review Panel
AN
Submission Type

Other clearances by Teleflex, Inc.

  • K153652 — ARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/Set (June 21, 2016)
  • K140110 — FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHET (March 27, 2015)
  • K141940 — CONCHASMART COLUMN (November 24, 2014)
  • K140556 — CONCHASMART BREATHING CIRCUIT (September 24, 2014)
  • K123974 — PERCUTANEOUS INTRODUCER KIT (February 21, 2013)
  • K121403 — CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER KIT AND SET (June 20, 2012)
  • K103658 — FLEXTIP PLUS CLOSED TIP EPIDURAL CATHERTER (May 16, 2012)
  • K861951 — MODIFIED TELEFLEX MEDICAL INTRODUCER CATHETER (June 19, 1986)
  • K860307 — PEEL AWAY & SPLIT SHEATH PERCU CATH INTRODUCER SET (May 20, 1986)

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  • K251611 — Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT (June 25, 2025)
  • K242717 — Laboratorios Biogalenic Sterile Water for Inhalation, USP (January 30, 2025)
  • K241778 — Hudson RCI Comfort Flo® CubCannula™ (December 19, 2024)
  • K240163 — Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus Cannula (September 27, 2024)
  • K234058 — F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041 (August 8, 2024)
  • K233707 — HFT150 (June 14, 2024)