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FDA 510(k)

SLICK ENDOTRACHEAL TUBE

K-Number: K812943 · 1981-11-06

ApplicantPolamedco, Inc.
Decision Date1981-11-06
Product CodeBTR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SLICK ENDOTRACHEAL TUBE is the device name listed in this FDA 510(k) record. The listed applicant is Polamedco, Inc.. It received FDA 510(k) clearance on 1981-11-06 under 510(k) number K812943. 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 SLICK ENDOTRACHEAL TUBE?

SLICK ENDOTRACHEAL TUBE is a medical device that received FDA 510(k) clearance on 1981-11-06. The listed applicant is Polamedco, Inc.. The 510(k) number is K812943.

When did SLICK ENDOTRACHEAL TUBE receive FDA 510(k) clearance?

SLICK ENDOTRACHEAL TUBE received FDA 510(k) clearance on 1981-11-06, under 510(k) number K812943.

Who is the listed applicant for SLICK ENDOTRACHEAL TUBE?

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

What is the FDA product code for SLICK ENDOTRACHEAL TUBE?

The FDA product code for SLICK ENDOTRACHEAL TUBE is BTR.

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Other records listing Polamedco, Inc. 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.

K983000CRICOTHYROTOMY TUBEK954383SURELOC CIRCUIT CONNECTORK953793INTROSCOPEK950713AIRGUIDE STYLETTEK933596GASTRIC, CATHETER, IRRIGATION & ASPIRATIONK950380FLEXTITIP STYLETTE

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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

View on FDA Database →

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

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