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FDA 510(k)

FUSTAR STEERABLE INTRODUCERS

K-Number: K100184 · 2011-02-14

ApplicantLifetech Scientific (Shenzhen) Co., Ltd.
Decision Date2011-02-14
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FUSTAR STEERABLE INTRODUCERS is the device name listed in this FDA 510(k) record. The listed applicant is Lifetech Scientific (Shenzhen) Co., Ltd.. It received FDA 510(k) clearance on 2011-02-14 under 510(k) number K100184. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FUSTAR STEERABLE INTRODUCERS?

FUSTAR STEERABLE INTRODUCERS is a medical device that received FDA 510(k) clearance on 2011-02-14. The listed applicant is Lifetech Scientific (Shenzhen) Co., Ltd.. The 510(k) number is K100184.

When did FUSTAR STEERABLE INTRODUCERS receive FDA 510(k) clearance?

FUSTAR STEERABLE INTRODUCERS received FDA 510(k) clearance on 2011-02-14, under 510(k) number K100184.

Who is the listed applicant for FUSTAR STEERABLE INTRODUCERS?

The FDA 510(k) record lists Lifetech Scientific (Shenzhen) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FUSTAR STEERABLE INTRODUCERS?

The FDA product code for FUSTAR STEERABLE INTRODUCERS is DQY.

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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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