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FDA 510(k)

EMT QUIK-COVER FLEXIBLE ENDOSCOPE BARRIER SHEATH, SERIES 1-7

K-Number: K061324 · 2006-06-20

ApplicantRtc Inc.-Memcath Technologies, LLC
Decision Date2006-06-20
Product CodeFED
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EMT QUIK-COVER FLEXIBLE ENDOSCOPE BARRIER SHEATH, SERIES 1-7 is the device name listed in this FDA 510(k) record. The listed applicant is Rtc Inc.-Memcath Technologies, LLC. It received FDA 510(k) clearance on 2006-06-20 under 510(k) number K061324. The device is classified under product code FED. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMT QUIK-COVER FLEXIBLE ENDOSCOPE BARRIER SHEATH, SERIES 1-7?

EMT QUIK-COVER FLEXIBLE ENDOSCOPE BARRIER SHEATH, SERIES 1-7 is a medical device that received FDA 510(k) clearance on 2006-06-20. The listed applicant is Rtc Inc.-Memcath Technologies, LLC. The 510(k) number is K061324.

When did EMT QUIK-COVER FLEXIBLE ENDOSCOPE BARRIER SHEATH, SERIES 1-7 receive FDA 510(k) clearance?

EMT QUIK-COVER FLEXIBLE ENDOSCOPE BARRIER SHEATH, SERIES 1-7 received FDA 510(k) clearance on 2006-06-20, under 510(k) number K061324.

Who is the listed applicant for EMT QUIK-COVER FLEXIBLE ENDOSCOPE BARRIER SHEATH, SERIES 1-7?

The FDA 510(k) record lists Rtc Inc.-Memcath Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EMT QUIK-COVER FLEXIBLE ENDOSCOPE BARRIER SHEATH, SERIES 1-7?

The FDA product code for EMT QUIK-COVER FLEXIBLE ENDOSCOPE BARRIER SHEATH, SERIES 1-7 is FED.

Related Clinical Trials

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Other records listing Rtc Inc.-Memcath Technologies, LLC 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.

K061663ENDOMEDICAL TECHNOLOGIES QUIK-COVER FLEXIBLE ENDOSCOPE BARRIER SHEATH FOR OTOLARYNGOSCOPES AND BRONCHOSCOPES

Related Devices (Code: FED)

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.

K260512Disposable Ureteral Access SheathYangzhou Fartley Medical Instrument Technology Co., Ltd.K262262Pathfinder Endoscope OvertubeNeptune Medical, Inc.K260410Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., Ltd.K261915Navigator™ Flex Ureteral Access Sheath SetBoston Scientific CorporationK260965CVAC Aspiration SystemCalyxo, Inc.K260521ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250)Zhuhai Pusen Medical Technology Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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