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FDA 510(k)

BLUE LINE(R) PDT(TM) PORTEX DIRECTIONAL TUBE

K-Number: K931735 · 1993-05-18

ApplicantSmiths Industries Medical Systems, Inc.
Decision Date1993-05-18
Product CodeBTR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BLUE LINE(R) PDT(TM) PORTEX DIRECTIONAL TUBE is the device name listed in this FDA 510(k) record. The listed applicant is Smiths Industries Medical Systems, Inc.. It received FDA 510(k) clearance on 1993-05-18 under 510(k) number K931735. 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 BLUE LINE(R) PDT(TM) PORTEX DIRECTIONAL TUBE?

BLUE LINE(R) PDT(TM) PORTEX DIRECTIONAL TUBE is a medical device that received FDA 510(k) clearance on 1993-05-18. The listed applicant is Smiths Industries Medical Systems, Inc.. The 510(k) number is K931735.

When did BLUE LINE(R) PDT(TM) PORTEX DIRECTIONAL TUBE receive FDA 510(k) clearance?

BLUE LINE(R) PDT(TM) PORTEX DIRECTIONAL TUBE received FDA 510(k) clearance on 1993-05-18, under 510(k) number K931735.

Who is the listed applicant for BLUE LINE(R) PDT(TM) PORTEX DIRECTIONAL TUBE?

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

What is the FDA product code for BLUE LINE(R) PDT(TM) PORTEX DIRECTIONAL TUBE?

The FDA product code for BLUE LINE(R) PDT(TM) PORTEX DIRECTIONAL TUBE is BTR.

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Other records listing Smiths Industries Medical Systems, 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.

K972385FENESTRATED FLEXIBLE D.I.C. TRACHEOSTOMY TUBE CUFFEDK965017REGIONAL ANESTHESIA TRAYSK962175PORTEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBEK962931SIMS PRO-VENT 250 (500) PLUS ARTERIAL BLOOD SAMPLING KITK963570SIMS ADULT LUMBAR PUNCTURE KIT (4800-20,4801-20,4806-22,4807-22)K960429PER-FIT PERCUTANEOUS TRACHEOSTOMY KIT W/PORTEX TRACHEOSTMY TUBE & DISP. INNER CANNULA

View all 22 devices →

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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