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FDA 510(k)

PEDIATRIC DOUBLE SWIVEL CONNECTOR

K-Number: K812000 · 1981-08-03

ApplicantMallinckrodt Critical Care
Decision Date1981-08-03
Product CodeBZA
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PEDIATRIC DOUBLE SWIVEL CONNECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Mallinckrodt Critical Care. It received FDA 510(k) clearance on 1981-08-03 under 510(k) number K812000. 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 PEDIATRIC DOUBLE SWIVEL CONNECTOR?

PEDIATRIC DOUBLE SWIVEL CONNECTOR is a medical device that received FDA 510(k) clearance on 1981-08-03. The listed applicant is Mallinckrodt Critical Care. The 510(k) number is K812000.

When did PEDIATRIC DOUBLE SWIVEL CONNECTOR receive FDA 510(k) clearance?

PEDIATRIC DOUBLE SWIVEL CONNECTOR received FDA 510(k) clearance on 1981-08-03, under 510(k) number K812000.

Who is the listed applicant for PEDIATRIC DOUBLE SWIVEL CONNECTOR?

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

What is the FDA product code for PEDIATRIC DOUBLE SWIVEL CONNECTOR?

The FDA product code for PEDIATRIC DOUBLE SWIVEL CONNECTOR is BZA.

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Other records listing Mallinckrodt Critical Care as applicant

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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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