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FDA 510(k)

TRACHEAL TUBE LASER SHIELD KIT

K-Number: K883096 · 1988-09-08

ApplicantAmerical Corp.
Decision Date1988-09-08
Product CodeBTR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TRACHEAL TUBE LASER SHIELD KIT is the device name listed in this FDA 510(k) record. The listed applicant is Americal Corp.. It received FDA 510(k) clearance on 1988-09-08 under 510(k) number K883096. 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 TRACHEAL TUBE LASER SHIELD KIT?

TRACHEAL TUBE LASER SHIELD KIT is a medical device that received FDA 510(k) clearance on 1988-09-08. The listed applicant is Americal Corp.. The 510(k) number is K883096.

When did TRACHEAL TUBE LASER SHIELD KIT receive FDA 510(k) clearance?

TRACHEAL TUBE LASER SHIELD KIT received FDA 510(k) clearance on 1988-09-08, under 510(k) number K883096.

Who is the listed applicant for TRACHEAL TUBE LASER SHIELD KIT?

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

What is the FDA product code for TRACHEAL TUBE LASER SHIELD KIT?

The FDA product code for TRACHEAL TUBE LASER SHIELD KIT is BTR.

Related Clinical Trials

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Other records listing Americal Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K874679TRACHEAL TUBE LASER SHIELD KIT

Related Devices (Code: BTR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251794Tenax® Laser Resistant Endotracheal TubeBryan Medical, Inc.K253437Spiro-VISTASpiro RoboticsK250173Shiley™ 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, LLCK243785Shiley™ 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, LLCK243579AeroJet Ventilation CatheterPipeline Medical Products, LLCK251499Frova 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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