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FDA 510(k)

RUSCH POLYFLEX STENT KIT

K-Number: K013266 · 2001-11-27

ApplicantRusch Intl.
Decision Date2001-11-27
Product CodeNYT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

RUSCH POLYFLEX STENT KIT is the device name listed in this FDA 510(k) record. The listed applicant is Rusch Intl.. It received FDA 510(k) clearance on 2001-11-27 under 510(k) number K013266. The device is classified under product code NYT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RUSCH POLYFLEX STENT KIT?

RUSCH POLYFLEX STENT KIT is a medical device that received FDA 510(k) clearance on 2001-11-27. The listed applicant is Rusch Intl.. The 510(k) number is K013266.

When did RUSCH POLYFLEX STENT KIT receive FDA 510(k) clearance?

RUSCH POLYFLEX STENT KIT received FDA 510(k) clearance on 2001-11-27, under 510(k) number K013266.

Who is the listed applicant for RUSCH POLYFLEX STENT KIT?

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

What is the FDA product code for RUSCH POLYFLEX STENT KIT?

The FDA product code for RUSCH POLYFLEX STENT KIT is NYT.

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Other records listing Rusch Intl. 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.

K033023INTERMITTENT URETHRAL CATHETERSK030559RUSCH POLYFLEX STENT FOR THE ESOPHAGUS W/INTRODUCER/DELIVERY SYSTEMK023666RUSCH GUIDED CHOLANGIOGRAPHY CATHETERK023918RUSCH CRYSTAL CLEAR TRACHEOSTOMY SETS, CUFFED AND CUFFLESSK023964RUSCH MICROLARYNGEAL TUBEK021540RUSCH EDGAR TUBE

View all 43 devices →

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.

K982614RUSCH POLYFLEX STENT KITRusch Intl.K953593RUSCH TRACHEAL BRONCHIAL Y STENTRusch, 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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