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FDA 510(k)

VAN ANDLE DILATION, EMERALD GUIDEWIRE, MODEL VAD6, 502-726

K-Number: K002650 · 2001-02-16

Decision Date2001-02-16
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

VAN ANDLE DILATION, EMERALD GUIDEWIRE, MODEL VAD6, 502-726 is the device name listed in this FDA 510(k) record. The listed applicant is Bentec Medical, Inc.. It received FDA 510(k) clearance on 2001-02-16 under 510(k) number K002650. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VAN ANDLE DILATION, EMERALD GUIDEWIRE, MODEL VAD6, 502-726?

VAN ANDLE DILATION, EMERALD GUIDEWIRE, MODEL VAD6, 502-726 is a medical device that received FDA 510(k) clearance on 2001-02-16. The listed applicant is Bentec Medical, Inc.. The 510(k) number is K002650.

When did VAN ANDLE DILATION, EMERALD GUIDEWIRE, MODEL VAD6, 502-726 receive FDA 510(k) clearance?

VAN ANDLE DILATION, EMERALD GUIDEWIRE, MODEL VAD6, 502-726 received FDA 510(k) clearance on 2001-02-16, under 510(k) number K002650.

Who is the listed applicant for VAN ANDLE DILATION, EMERALD GUIDEWIRE, MODEL VAD6, 502-726?

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

What is the FDA product code for VAN ANDLE DILATION, EMERALD GUIDEWIRE, MODEL VAD6, 502-726?

The FDA product code for VAN ANDLE DILATION, EMERALD GUIDEWIRE, MODEL VAD6, 502-726 is FGE.

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.

Other records listing Bentec Medical, 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.

Related Devices (Code: FGE)

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.

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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