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FDA 510(k)

RUSCH SINGLE LUMEN BRONCHIAL TUVBE SET, STERILE, FOR LEFT & RIGHT SIDED BRONCHIAL INTUBATION

K-Number: K953963 · 1995-11-27

ApplicantRusch, Inc.
Decision Date1995-11-27
Product CodeBTS
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

RUSCH SINGLE LUMEN BRONCHIAL TUVBE SET, STERILE, FOR LEFT & RIGHT SIDED BRONCHIAL INTUBATION is the device name listed in this FDA 510(k) record. The listed applicant is Rusch, Inc.. It received FDA 510(k) clearance on 1995-11-27 under 510(k) number K953963. 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 RUSCH SINGLE LUMEN BRONCHIAL TUVBE SET, STERILE, FOR LEFT & RIGHT SIDED BRONCHIAL INTUBATION?

RUSCH SINGLE LUMEN BRONCHIAL TUVBE SET, STERILE, FOR LEFT & RIGHT SIDED BRONCHIAL INTUBATION is a medical device that received FDA 510(k) clearance on 1995-11-27. The listed applicant is Rusch, Inc.. The 510(k) number is K953963.

When did RUSCH SINGLE LUMEN BRONCHIAL TUVBE SET, STERILE, FOR LEFT & RIGHT SIDED BRONCHIAL INTUBATION receive FDA 510(k) clearance?

RUSCH SINGLE LUMEN BRONCHIAL TUVBE SET, STERILE, FOR LEFT & RIGHT SIDED BRONCHIAL INTUBATION received FDA 510(k) clearance on 1995-11-27, under 510(k) number K953963.

Who is the listed applicant for RUSCH SINGLE LUMEN BRONCHIAL TUVBE SET, STERILE, FOR LEFT & RIGHT SIDED BRONCHIAL INTUBATION?

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

What is the FDA product code for RUSCH SINGLE LUMEN BRONCHIAL TUVBE SET, STERILE, FOR LEFT & RIGHT SIDED BRONCHIAL INTUBATION?

The FDA product code for RUSCH SINGLE LUMEN BRONCHIAL TUVBE SET, STERILE, FOR LEFT & RIGHT SIDED BRONCHIAL INTUBATION is BTS.

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Other records listing Rusch, Inc. 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.

K010420RUSCH MMG/O'NEIL CATHETERK993528RUSCH EMERGENCY MASKK993194RUSCH MANUAL RESUSCITATOR BAGK980870RUSCH SILICONE FOLEY CATHETERK974419RUSCH SIMPLASTIC COUNCILL TIP CATHETERK963779RUSCH ENTERAL FEEDING TUBE

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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.

K951091RUSCH ENDOBRONCHIAL TUBE SETSRusch Intl.K902116MODIFIED ENDOBRONCHIAL TUBEConcord/PortexK834565ENDOBRONCHIAL TWIN LUMEN TUBEPortex, Inc.K833297BRONCHOSCOPY TUBE W/ULTRA LOCUFFSurgitekK771219BRONCHO-CATHMallinckrodt Critical Care

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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