FDA 510(k)

VT-1

K-Number: K012619 · 2001-11-09

Decision Date2001-11-09

Product CodeLKY

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

VT-1 is the device name listed in this FDA 510(k) record. The listed applicant is Vts, Inc.. It received FDA 510(k) clearance on 2001-11-09 under 510(k) number K012619. The device is classified under product code LKY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VT-1?

VT-1 is a medical device that received FDA 510(k) clearance on 2001-11-09. The listed applicant is Vts, Inc.. The 510(k) number is K012619.

When did VT-1 receive FDA 510(k) clearance?

VT-1 received FDA 510(k) clearance on 2001-11-09, under 510(k) number K012619.

Who is the listed applicant for VT-1?

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

What is the FDA product code for VT-1?

The FDA product code for VT-1 is LKY.

Other records listing Vts, 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.

K012639SE-300 VACUUM THERAPY SYSTEM K012620SE-200 K012662SE-100 VACUUM ERECTION DEVICE K992442V.T.S., INC. (V.T.-3)

Related Devices (Code: LKY)

K041573NANMA VACUUM PUMP PROXZEK MODEL 2M9498SNanma Mfg Co., Ltd.K032776VACURECT VACUUM CONSTRICTION DEVICEVacurect Manufacturing (Pty) , Ltd.K030119NANMA ADJUSTABLE CONSTRICTION RINGNanma Mfg Co., Ltd.K030913NANMA VACUUM PUMPNanma Mfg Co., Ltd.K013113MODIFICATION TO NANMA VACUUM PUMPNanma Mfg Co., Ltd.K013051NANMA ADJUSTABLE CONSTRICTION RINGNanma Mfg 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.