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FDA 510(k)

AIRWAY CONNECTOR WITH FLEX TUBE

K-Number: K942392 · 1994-08-22

ApplicantMallinckrodt Medical
Decision Date1994-08-22
Product CodeBZA
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AIRWAY CONNECTOR WITH FLEX TUBE is the device name listed in this FDA 510(k) record. The listed applicant is Mallinckrodt Medical. It received FDA 510(k) clearance on 1994-08-22 under 510(k) number K942392. The device is classified under product code BZA. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AIRWAY CONNECTOR WITH FLEX TUBE?

AIRWAY CONNECTOR WITH FLEX TUBE is a medical device that received FDA 510(k) clearance on 1994-08-22. The listed applicant is Mallinckrodt Medical. The 510(k) number is K942392.

When did AIRWAY CONNECTOR WITH FLEX TUBE receive FDA 510(k) clearance?

AIRWAY CONNECTOR WITH FLEX TUBE received FDA 510(k) clearance on 1994-08-22, under 510(k) number K942392.

Who is the listed applicant for AIRWAY CONNECTOR WITH FLEX TUBE?

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

What is the FDA product code for AIRWAY CONNECTOR WITH FLEX TUBE?

The FDA product code for AIRWAY CONNECTOR WITH FLEX TUBE is BZA.

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Other records listing Mallinckrodt 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.

K082520SEALGUARD EVAC ENDOTRACHEAL AND ENDOTRACHEAL TUBESK051416SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND INNER CANNULAK972258HI-CARE CLOSED SUCTION SYSTEMK971267SHILEY EXTENDED LENGTH, DISPOSABLE CANNULA, TRACHEOSTOMY TUBE: CUFFED, DISTAL EXTENSION, CUFFED, PROXIMAL EXTENSION, CUFK963732PERCUTANEOUS DUAL CANNULA TRACHEOSTOMY TUBE WITH LOW PRESSURE/LOW PROFILE CUFF AND DISPOSABLE INNER CANNULAK955721CUFFED OROPHARYNGEAL AIRWAY (COPA)

View all 43 devices →

Related Devices (Code: BZA)

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.

K083702TRACH-ASSISTMergenet MedicalK954383SURELOC CIRCUIT CONNECTORPolamedco, Inc.K954197DISPOSABLE FLEX TUBEEngstrom MedicalK953786UNICOR, INC. CONNECTORS & AIRWAY EXTENSIONSUnicor, Inc.K952824NEO-LINK, DISPOSABLE NEONATAL AIR WAY CONNECTORIntertex Medical, Inc.K951345DISPOSABLE AIRWAY CONNECTORS FOR GAS SAMPLINGCatheter Research, 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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