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510(k) K223258

TNI Clear-Guard™ 3 angled breathing filter (1545020) by Intersurgical , Ltd. — Product Code CAH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 2023
Date Received
October 21, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filter, Bacterial, Breathing-Circuit
Device Class
Class II
Regulation Number
868.5260
Review Panel
HO
Submission Type

Other clearances by Intersurgical , Ltd.

  • K122077 — MANOMETER (January 10, 2013)
  • K122075 — DISPOSABLE GAS SAMPLING LINE WITH AND WITHOUT IN-LINE FILTER (December 20, 2012)
  • K121026 — FLO-GUARD BREATHING FILTER (November 2, 2012)
  • K092451 — INTERSURGICAL INTER-THERM BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER, INTE (October 29, 2010)
  • K092129 — INTERSURGICAL HEATED WIRE BREATHING SYSTEMS AND HUMIDIFICATION CHAMBERS, MODEL 2 (May 18, 2010)
  • K092409 — HYDRO-GUARD MINI BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER AND AIR-GUARD (March 10, 2010)
  • K032322 — CLEAR-THERM MICRO HME, MODEL 1441 (May 13, 2004)
  • K024270 — CLEAR-THERM 3 HMEF, CLEAR-THERM 3 WITH SUPERSET CATHETER MOUNT,CLEAR-THERM WITH (June 24, 2003)
  • K990949 — CLEAR-GUARD II, CLEAR-THERM HMEF, CLEAR-THERM HMEF W/ FLEXTUBE, CLEAR GUARD 11 W (June 15, 1999)
  • K983610 — CLEAR-GUARD MIDI, CLEAR-GUARD MIDI W/FLEXTUBE, CLEAR-THERM MINI, CLEAR-THERM MIN (April 30, 1999)

Other clearances for product code CAH

  • K241339 — Besmed Bacterial Filter and HMEF (November 14, 2024)
  • K222917 — Breathing circuit bacterial/viral filter (February 15, 2024)
  • K230483 — Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15) (September 16, 2023)
  • K221472 — Filter and HME/Filter (February 8, 2023)
  • K221836 — Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus (December 7, 2022)
  • K221250 — EasyOne Filter (November 22, 2022)
  • K210352 — GGM Breathing Circuit Bacterial Filter (March 27, 2022)
  • K211286 — Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture Exchanger (November 16, 2021)
  • K202459 — Bact-Trap Filter, Bact-Trap Mini, Bact-Trap Midi, Pharma Mini HME/Filter, Bact-H (September 26, 2021)
  • K191909 — HepaShield Bacterial Viral Breathing System Filter (March 23, 2020)