FDA 510(k)

THE PERCUQUICK SET FOR PERCUTANEOUS DILATION TRACHEOSTOMY

K-Number: K011210 · 2001-08-15

Decision Date2001-08-15

Product CodeJOH

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

THE PERCUQUICK SET FOR PERCUTANEOUS DILATION TRACHEOSTOMY is the device name listed in this FDA 510(k) record. The listed applicant is Rusch Intl.. It received FDA 510(k) clearance on 2001-08-15 under 510(k) number K011210. The device is classified under product code JOH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE PERCUQUICK SET FOR PERCUTANEOUS DILATION TRACHEOSTOMY?

THE PERCUQUICK SET FOR PERCUTANEOUS DILATION TRACHEOSTOMY is a medical device that received FDA 510(k) clearance on 2001-08-15. The listed applicant is Rusch Intl.. The 510(k) number is K011210.

When did THE PERCUQUICK SET FOR PERCUTANEOUS DILATION TRACHEOSTOMY receive FDA 510(k) clearance?

THE PERCUQUICK SET FOR PERCUTANEOUS DILATION TRACHEOSTOMY received FDA 510(k) clearance on 2001-08-15, under 510(k) number K011210.

Who is the listed applicant for THE PERCUQUICK SET FOR PERCUTANEOUS DILATION TRACHEOSTOMY?

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 THE PERCUQUICK SET FOR PERCUTANEOUS DILATION TRACHEOSTOMY?

The FDA product code for THE PERCUQUICK SET FOR PERCUTANEOUS DILATION TRACHEOSTOMY is JOH.

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Other records listing Rusch Intl. as applicant

K033023INTERMITTENT URETHRAL CATHETERS K030559RUSCH POLYFLEX STENT FOR THE ESOPHAGUS W/INTRODUCER/DELIVERY SYSTEM K023666RUSCH GUIDED CHOLANGIOGRAPHY CATHETER K023918RUSCH CRYSTAL CLEAR TRACHEOSTOMY SETS, CUFFED AND CUFFLESS K023964RUSCH MICROLARYNGEAL TUBE K021540RUSCH EDGAR TUBE

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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.