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FDA 510(k)

PARKER FLEX-TIP TRACHEAL TUBE

K-Number: K984528 · 1999-07-15

ApplicantParker Medical Assoc.
Decision Date1999-07-15
Product CodeBTR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PARKER FLEX-TIP TRACHEAL TUBE is the device name listed in this FDA 510(k) record. The listed applicant is Parker Medical Assoc.. It received FDA 510(k) clearance on 1999-07-15 under 510(k) number K984528. 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 PARKER FLEX-TIP TRACHEAL TUBE?

PARKER FLEX-TIP TRACHEAL TUBE is a medical device that received FDA 510(k) clearance on 1999-07-15. The listed applicant is Parker Medical Assoc.. The 510(k) number is K984528.

When did PARKER FLEX-TIP TRACHEAL TUBE receive FDA 510(k) clearance?

PARKER FLEX-TIP TRACHEAL TUBE received FDA 510(k) clearance on 1999-07-15, under 510(k) number K984528.

Who is the listed applicant for PARKER FLEX-TIP TRACHEAL TUBE?

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

What is the FDA product code for PARKER FLEX-TIP TRACHEAL TUBE?

The FDA product code for PARKER FLEX-TIP TRACHEAL TUBE is BTR.

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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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