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510(k) K102618

VENTSTAR HEATED, INFINITY ID BREATHING CIRCUIT HEATED by Draeger Medical AG & Co. KG — Product Code BTT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 2010
Date Received
September 13, 2010
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 Draeger Medical AG & Co. KG

  • K092029 — VENTSTAR RESUSCITAIRE, MODEL MP00311, VENTSTAR RESUSCITAIRE CEU, MODEL MP00310 (August 6, 2010)
  • K100941 — INFINITY MCABLE - MAINSTREAM CO2 (April 23, 2010)
  • K092999 — NBP CUFF (November 24, 2009)
  • K083050 — EVITE XL (December 29, 2008)
  • K081447 — FOURTH GAS MODULE WITH CO2 FOR PRIMUS US APOLLO (October 8, 2008)
  • K081743 — CLASSICSTAR NV SE AND NOVASTAR NV SE AND AAV FULL FACE MASKS (September 22, 2008)
  • K072884 — FABIUS MRI (July 30, 2008)
  • K072885 — CARINA SYSTEM, MODEL 8419350; CARINA BASIC DEVICE, MODEL 5704110 (April 7, 2008)
  • K072002 — FILTER CARESTAR 30; FILTER SAFESTAR 55; FILTER/HME TWINSTAR 55 (January 31, 2008)

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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)