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510(k) K161813

Frova Intubating Introducer by William Cook Europe Aps — Product Code BTR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 2017
Date Received
July 1, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Tracheal (W/Wo Connector)
Device Class
Class II
Regulation Number
868.5730
Review Panel
AN
Submission Type

Other clearances by William Cook Europe Aps

  • K251596 — Lunderquist Extra Stiff Wire Guide (November 9, 2025)
  • K251499 — Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer (C- (June 11, 2025)
  • K233680 — Celect Platinum Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM- (January 18, 2024)
  • K220137 — Lunderquist Extra Stiff Wire Guide (February 17, 2022)
  • K211875 — Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect (July 28, 2021)
  • K211874 — Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena (July 28, 2021)
  • K171513 — Lunderquist Extra Stiff Wire Guide (December 7, 2017)
  • K172557 — Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Gunther Tulip Vena (November 20, 2017)
  • K172584 — Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena (November 20, 2017)
  • K171712 — Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect (August 7, 2017)

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  • K243579 — AeroJet Ventilation Catheter (August 13, 2025)
  • K251499 — Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer (C- (June 11, 2025)
  • K250243 — ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); (May 20, 2025)
  • K242495 — LMA Fastrach ETT SU (April 29, 2025)
  • K241451 — Rusch Endotracheal Tubes (Reinforced); Rusch Endotracheal Tubes (Safety Clear); (February 11, 2025)
  • K233341 — Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, (May 20, 2024)
  • K223130 — Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP ( (August 30, 2023)
  • K211543 — Wei Nasal Jet Tube (July 21, 2022)