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FDA 510(k)

MESH FENESTRATED INTRODUCER NEEDLE (MESH INTRODUCER NEEDLE)

K-Number: K071375 · 2007-12-21

ApplicantDisc-O-Tech Medical Technologies, Ltd.
Decision Date2007-12-21
Product CodeNDN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MESH FENESTRATED INTRODUCER NEEDLE (MESH 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 2007-12-21 under 510(k) number K071375. 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 MESH FENESTRATED INTRODUCER NEEDLE (MESH INTRODUCER NEEDLE)?

MESH FENESTRATED INTRODUCER NEEDLE (MESH INTRODUCER NEEDLE) is a medical device that received FDA 510(k) clearance on 2007-12-21. The listed applicant is Disc-O-Tech Medical Technologies, Ltd.. The 510(k) number is K071375.

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

MESH FENESTRATED INTRODUCER NEEDLE (MESH INTRODUCER NEEDLE) received FDA 510(k) clearance on 2007-12-21, under 510(k) number K071375.

Who is the listed applicant for MESH FENESTRATED INTRODUCER NEEDLE (MESH 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 MESH FENESTRATED INTRODUCER NEEDLE (MESH INTRODUCER NEEDLE)?

The FDA product code for MESH FENESTRATED INTRODUCER NEEDLE (MESH INTRODUCER NEEDLE) is NDN.

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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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