Decision Date1985-02-21
Product CodeBTR
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
S.E.T. TUBE is the device name listed in this FDA 510(k) record. The listed applicant is Bfw Laboratories, Inc.. It received FDA 510(k) clearance on 1985-02-21 under 510(k) number K843988. 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 S.E.T. TUBE?
S.E.T. TUBE is a medical device that received FDA 510(k) clearance on 1985-02-21. The listed applicant is Bfw Laboratories, Inc.. The 510(k) number is K843988.
When did S.E.T. TUBE receive FDA 510(k) clearance?
S.E.T. TUBE received FDA 510(k) clearance on 1985-02-21, under 510(k) number K843988.
Who is the listed applicant for S.E.T. TUBE?
The FDA 510(k) record lists Bfw Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for S.E.T. TUBE?
The FDA product code for S.E.T. TUBE is BTR.
Other records listing Bfw Laboratories, 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.
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.