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FDA 510(k)

SURGITEK ULTRA-LO CUFF

K-Number: K830504 · 1983-04-12

ApplicantMec/Surgitek Products
Decision Date1983-04-12
Product CodeBTR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SURGITEK ULTRA-LO CUFF is the device name listed in this FDA 510(k) record. The listed applicant is Mec/Surgitek Products. It received FDA 510(k) clearance on 1983-04-12 under 510(k) number K830504. 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 SURGITEK ULTRA-LO CUFF?

SURGITEK ULTRA-LO CUFF is a medical device that received FDA 510(k) clearance on 1983-04-12. The listed applicant is Mec/Surgitek Products. The 510(k) number is K830504.

When did SURGITEK ULTRA-LO CUFF receive FDA 510(k) clearance?

SURGITEK ULTRA-LO CUFF received FDA 510(k) clearance on 1983-04-12, under 510(k) number K830504.

Who is the listed applicant for SURGITEK ULTRA-LO CUFF?

The FDA 510(k) record lists Mec/Surgitek Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SURGITEK ULTRA-LO CUFF?

The FDA product code for SURGITEK ULTRA-LO CUFF is BTR.

Related Clinical Trials

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Other records listing Mec/Surgitek Products 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.

K831446SURGITEK NEPHROSTENT KIT

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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