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FDA 510(k)

CONFIDENCE FENESTRATED INTRODUCER NEEDLE

K-Number: K063067 · 2006-11-03

ApplicantDisc-O-Tech Medical Technologies, Ltd.
Decision Date2006-11-03
Product CodeNDN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CONFIDENCE FENESTRATED INTRODUCER NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Disc-O-Tech Medical Technologies, Ltd.. It received FDA 510(k) clearance on 2006-11-03 under 510(k) number K063067. The device is classified under product code NDN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONFIDENCE FENESTRATED INTRODUCER NEEDLE?

CONFIDENCE FENESTRATED INTRODUCER NEEDLE is a medical device that received FDA 510(k) clearance on 2006-11-03. The listed applicant is Disc-O-Tech Medical Technologies, Ltd.. The 510(k) number is K063067.

When did CONFIDENCE FENESTRATED INTRODUCER NEEDLE receive FDA 510(k) clearance?

CONFIDENCE FENESTRATED INTRODUCER NEEDLE received FDA 510(k) clearance on 2006-11-03, under 510(k) number K063067.

Who is the listed applicant for CONFIDENCE FENESTRATED INTRODUCER NEEDLE?

The FDA 510(k) record lists Disc-O-Tech Medical Technologies, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CONFIDENCE FENESTRATED INTRODUCER NEEDLE?

The FDA product code for CONFIDENCE FENESTRATED INTRODUCER NEEDLE is NDN.

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Other records listing Disc-O-Tech Medical Technologies, Ltd. 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.

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Official Source

View on FDA Database →

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

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