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FDA 510(k)

PORTEX EMERGENCY CRICOTHYROIDOTOMY KIT

K-Number: K050166 · 2005-05-26

ApplicantSmiths Medical
Decision Date2005-05-26
Product CodeBWC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PORTEX EMERGENCY CRICOTHYROIDOTOMY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Smiths Medical. It received FDA 510(k) clearance on 2005-05-26 under 510(k) number K050166. The device is classified under product code BWC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PORTEX EMERGENCY CRICOTHYROIDOTOMY KIT?

PORTEX EMERGENCY CRICOTHYROIDOTOMY KIT is a medical device that received FDA 510(k) clearance on 2005-05-26. The listed applicant is Smiths Medical. The 510(k) number is K050166.

When did PORTEX EMERGENCY CRICOTHYROIDOTOMY KIT receive FDA 510(k) clearance?

PORTEX EMERGENCY CRICOTHYROIDOTOMY KIT received FDA 510(k) clearance on 2005-05-26, under 510(k) number K050166.

Who is the listed applicant for PORTEX EMERGENCY CRICOTHYROIDOTOMY KIT?

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

What is the FDA product code for PORTEX EMERGENCY CRICOTHYROIDOTOMY KIT?

The FDA product code for PORTEX EMERGENCY CRICOTHYROIDOTOMY KIT is BWC.

Related Clinical Trials

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.

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Other records listing Smiths Medical 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.

K181660Acapella Choice Blue Vibratory PEP DeviceK041348PORTEX ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT_WITH SERIAL DILATORS OR SINGLE STAGE DILATOR, BLUE LINE ULTRA

Related Devices (Code: BWC)

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.

K200190ScalpelCricVBM Medizintechnik GmbHK160200Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyrotomy Catheter SetCook IncorporatedK153761Emergency Transtracheal Airway CatheterCook IncorporatedK130405RUSCH EASYCRIC EMERGENCY CRICOTHYROTOMY SETTeleflex MedicalK013241ARNDT EMERGENCY CRICOTHYROTOMY CATHETER SETCook, Inc.K013252PATIL EMERGENCY CRICOTHYROTOMY CATHETER SETCook, Inc.

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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