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FDA 510(k)

MEMCATH UROLOGY INTRODUCER SHEATH, MODEL 201

K-Number: K000767 · 2000-06-05

ApplicantMemcath Technologies, LLC
Decision Date2000-06-05
Product CodeKNY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MEMCATH UROLOGY INTRODUCER SHEATH, MODEL 201 is the device name listed in this FDA 510(k) record. The listed applicant is Memcath Technologies, LLC. It received FDA 510(k) clearance on 2000-06-05 under 510(k) number K000767. The device is classified under product code KNY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEMCATH UROLOGY INTRODUCER SHEATH, MODEL 201?

MEMCATH UROLOGY INTRODUCER SHEATH, MODEL 201 is a medical device that received FDA 510(k) clearance on 2000-06-05. The listed applicant is Memcath Technologies, LLC. The 510(k) number is K000767.

When did MEMCATH UROLOGY INTRODUCER SHEATH, MODEL 201 receive FDA 510(k) clearance?

MEMCATH UROLOGY INTRODUCER SHEATH, MODEL 201 received FDA 510(k) clearance on 2000-06-05, under 510(k) number K000767.

Who is the listed applicant for MEMCATH UROLOGY INTRODUCER SHEATH, MODEL 201?

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

What is the FDA product code for MEMCATH UROLOGY INTRODUCER SHEATH, MODEL 201?

The FDA product code for MEMCATH UROLOGY INTRODUCER SHEATH, MODEL 201 is KNY.

Related Clinical Trials

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.

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Other records listing 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.

K993226MEMCATH UROLOGY CATHETER, MODEL 101 -000 - 006

Related Devices (Code: KNY)

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.

K260919Transurethral Catheter Safety Valve (TUCSV) (80050)Class Medical , Ltd.K182144Bi-Flex EvoPromepla SamK162356Vesair Cystoscopic SheathSolace TherapeuticsK131803GUARDIAN URETHRAL SHEATHSolace TherapeuticsK123170VARI-PASS VARIABLE LENGTH ACCESS SHEATHOlympus Surgical Technologies AmericaK120160ROCAMED ROCAUS PLATINUMPromepla Sam

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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