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FDA 510(k)

BRONCHO-CATH

K-Number: K771219 · 1977-08-04

ApplicantMallinckrodt Critical Care
Decision Date1977-08-04
Product CodeBTS
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BRONCHO-CATH 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 1977-08-04 under 510(k) number K771219. The device is classified under product code BTS. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BRONCHO-CATH?

BRONCHO-CATH is a medical device that received FDA 510(k) clearance on 1977-08-04. The listed applicant is Mallinckrodt Critical Care. The 510(k) number is K771219.

When did BRONCHO-CATH receive FDA 510(k) clearance?

BRONCHO-CATH received FDA 510(k) clearance on 1977-08-04, under 510(k) number K771219.

Who is the listed applicant for BRONCHO-CATH?

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 BRONCHO-CATH?

The FDA product code for BRONCHO-CATH is BTS.

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Other records listing Mallinckrodt Critical Care as applicant

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Related Devices (Code: BTS)

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.

K953963RUSCH SINGLE LUMEN BRONCHIAL TUVBE SET, STERILE, FOR LEFT & RIGHT SIDED BRONCHIAL INTUBATIONRusch, Inc.K951091RUSCH ENDOBRONCHIAL TUBE SETSRusch Intl.K902116MODIFIED ENDOBRONCHIAL TUBEConcord/PortexK834565ENDOBRONCHIAL TWIN LUMEN TUBEPortex, Inc.K833297BRONCHOSCOPY TUBE W/ULTRA LOCUFFSurgitek

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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