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FDA 510(k)

RUSCH REINFORCED TRACHAEL TUBE CUFFED, STERILE

K-Number: K955495 · 1996-06-27

ApplicantRusch, Inc.
Decision Date1996-06-27
Product CodeBTR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

RUSCH REINFORCED TRACHAEL TUBE CUFFED, STERILE is the device name listed in this FDA 510(k) record. The listed applicant is Rusch, Inc.. It received FDA 510(k) clearance on 1996-06-27 under 510(k) number K955495. 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 RUSCH REINFORCED TRACHAEL TUBE CUFFED, STERILE?

RUSCH REINFORCED TRACHAEL TUBE CUFFED, STERILE is a medical device that received FDA 510(k) clearance on 1996-06-27. The listed applicant is Rusch, Inc.. The 510(k) number is K955495.

When did RUSCH REINFORCED TRACHAEL TUBE CUFFED, STERILE receive FDA 510(k) clearance?

RUSCH REINFORCED TRACHAEL TUBE CUFFED, STERILE received FDA 510(k) clearance on 1996-06-27, under 510(k) number K955495.

Who is the listed applicant for RUSCH REINFORCED TRACHAEL TUBE CUFFED, STERILE?

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

What is the FDA product code for RUSCH REINFORCED TRACHAEL TUBE CUFFED, STERILE?

The FDA product code for RUSCH REINFORCED TRACHAEL TUBE CUFFED, STERILE is BTR.

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Other records listing Rusch, 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.

K010420RUSCH MMG/O'NEIL CATHETERK993528RUSCH EMERGENCY MASKK993194RUSCH MANUAL RESUSCITATOR BAGK980870RUSCH SILICONE FOLEY CATHETERK974419RUSCH SIMPLASTIC COUNCILL TIP CATHETERK963779RUSCH ENTERAL FEEDING TUBE

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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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