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FDA 510(k)

RUSCH TRACHEAL BRONCHIAL Y STENT

K-Number: K953593 · 1995-10-13

ApplicantRusch, Inc.
Decision Date1995-10-13
Product CodeNYT
Advisory CommitteeSU
DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

RUSCH TRACHEAL BRONCHIAL Y STENT is the device name listed in this FDA 510(k) record. The listed applicant is Rusch, Inc.. It received FDA 510(k) clearance on 1995-10-13 under 510(k) number K953593. The device is classified under product code NYT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent - Subject to Tracking Reg..

Frequently Asked Questions

What is the RUSCH TRACHEAL BRONCHIAL Y STENT?

RUSCH TRACHEAL BRONCHIAL Y STENT is a medical device that received FDA 510(k) clearance on 1995-10-13. The listed applicant is Rusch, Inc.. The 510(k) number is K953593.

When did RUSCH TRACHEAL BRONCHIAL Y STENT receive FDA 510(k) clearance?

RUSCH TRACHEAL BRONCHIAL Y STENT received FDA 510(k) clearance on 1995-10-13, under 510(k) number K953593.

Who is the listed applicant for RUSCH TRACHEAL BRONCHIAL Y STENT?

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 TRACHEAL BRONCHIAL Y STENT?

The FDA product code for RUSCH TRACHEAL BRONCHIAL Y STENT is NYT.

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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: NYT)

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.

K013266RUSCH POLYFLEX STENT KITRusch Intl.K982614RUSCH POLYFLEX STENT KITRusch Intl.

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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