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FDA 510(k)

SILICONE TRACHEAL T-TUBES

K-Number: K013321 · 2002-06-04

ApplicantTechnical Products, Inc.
Decision Date2002-06-04
Product CodeBTR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SILICONE TRACHEAL T-TUBES is the device name listed in this FDA 510(k) record. The listed applicant is Technical Products, Inc.. It received FDA 510(k) clearance on 2002-06-04 under 510(k) number K013321. 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 SILICONE TRACHEAL T-TUBES?

SILICONE TRACHEAL T-TUBES is a medical device that received FDA 510(k) clearance on 2002-06-04. The listed applicant is Technical Products, Inc.. The 510(k) number is K013321.

When did SILICONE TRACHEAL T-TUBES receive FDA 510(k) clearance?

SILICONE TRACHEAL T-TUBES received FDA 510(k) clearance on 2002-06-04, under 510(k) number K013321.

Who is the listed applicant for SILICONE TRACHEAL T-TUBES?

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

What is the FDA product code for SILICONE TRACHEAL T-TUBES?

The FDA product code for SILICONE TRACHEAL T-TUBES is BTR.

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Other records listing Technical Products, 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.

K973385OVAL SHAPESK973166DOW CORNING SILASTIC ELASTOMER Q7-4750K971472SIL-TEC NONREINFORCED SHEETING, REINFORCED SHEETING, RADIOPAQUE SHEETING, REINFORCED RADIOPAQUE SHEETING, EXTRA FIRM GRAK971613SIL-TEC SMALL/LARGE BORE TUBING/SIL-TEC HIGH DUROMETER TUBING/SIL-TEC RADIOPAQUE TUBINGK954116SILICONE MALECOT CATHETER WITH PEZZER/MUSHROOM TIP

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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