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FDA 510(k)

ULTRA CATHETER SET

K-Number: K001115 · 2000-05-17

ApplicantLyco Enterprises, Inc.
Decision Date2000-05-17
Product CodeLKF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ULTRA CATHETER SET is the device name listed in this FDA 510(k) record. The listed applicant is Lyco Enterprises, Inc.. It received FDA 510(k) clearance on 2000-05-17 under 510(k) number K001115. The device is classified under product code LKF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRA CATHETER SET?

ULTRA CATHETER SET is a medical device that received FDA 510(k) clearance on 2000-05-17. The listed applicant is Lyco Enterprises, Inc.. The 510(k) number is K001115.

When did ULTRA CATHETER SET receive FDA 510(k) clearance?

ULTRA CATHETER SET received FDA 510(k) clearance on 2000-05-17, under 510(k) number K001115.

Who is the listed applicant for ULTRA CATHETER SET?

The FDA 510(k) record lists Lyco Enterprises, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ULTRA CATHETER SET?

The FDA product code for ULTRA CATHETER SET is LKF.

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 Lyco Enterprises, 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.

K943494HSG CATHETER SET FOR HYSTERSALPINGOGRAPHY

Related Devices (Code: LKF)

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.

K253403FemVue® Controlled Saline-Air Device (FSA-300)Femasys, Inc.K252260RELIEEV HSG Catheter (HSG7FA1)Li Medical Corporation , Ltd.K242002FemVue MINI Saline-Air DeviceFemasys, Inc.K240364RELIEEV Uterine Manipulator Injector (CUMI 5.0)Li Medical Corporation , Ltd.K241693FemChec Controlled Saline-Air Device (FCD-250)Femasys, Inc.K222798Rejoni Intrauterine CatheterRejoni, Inc.

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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