FDA 510(k)

CONNELL-STEPHENS ENDO ANESS TUBE

K-Number: K895132 · 1989-10-13

Decision Date1989-10-13

Product CodeBTR

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

CONNELL-STEPHENS ENDO ANESS TUBE is the device name listed in this FDA 510(k) record. The listed applicant is The Traumafuse Co.. It received FDA 510(k) clearance on 1989-10-13 under 510(k) number K895132. The device is classified under product code BTR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONNELL-STEPHENS ENDO ANESS TUBE?

CONNELL-STEPHENS ENDO ANESS TUBE is a medical device that received FDA 510(k) clearance on 1989-10-13. The listed applicant is The Traumafuse Co.. The 510(k) number is K895132.

When did CONNELL-STEPHENS ENDO ANESS TUBE receive FDA 510(k) clearance?

CONNELL-STEPHENS ENDO ANESS TUBE received FDA 510(k) clearance on 1989-10-13, under 510(k) number K895132.

Who is the listed applicant for CONNELL-STEPHENS ENDO ANESS TUBE?

The FDA 510(k) record lists The Traumafuse Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CONNELL-STEPHENS ENDO ANESS TUBE?

The FDA product code for CONNELL-STEPHENS ENDO ANESS TUBE is BTR.

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Other records listing The Traumafuse Co. as applicant

K895162TRAUMAFUSE TRACH SHIELD K894721TRAUMAFUSE PERFUSION PRESSURE RELIEF VALVE K890077TRAUMAFUSE RAPID INFUSION DEVICE

Related Devices (Code: BTR)

K251794Tenax® Laser Resistant Endotracheal TubeBryan Medical, Inc.K253437Spiro-VISTASpiro Robotics K250173Shiley™ Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley™ Nasal RAE Tracheal Tube Cuffless, Murphy Eye (114-XX) Shiley™ Oral RAE Tracheal Tube Cuffed, Murphy Eye (115-XX) Shiley™ Oral RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (115-XXOR) Shiley™ Nasal RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (119-XXNR)Covidien, LLC K243785Shiley™ Oral/Nasal Tracheal Tube with TaperGuard™ Cuff Reinforced, Murphy Eye Shiley™ Tracheal Tube TaperGuard™ Cuff Reinforced with Stylet Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley™ Oral/Nasal Tracheal Tube Cuffless ReinforcedCovidien, LLC K243579AeroJet Ventilation CatheterPipeline Medical Products, LLC K251499Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer (C-CAE-14.0-70-FI); Frova Intubating Introducer (C-CAE-14.0-70-FIC); Frova Intubating Introducer (C-CAE-14.0-70-FIC-SPOPS)William Cook Europe Aps

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.