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FDA 510(k)

Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand)

K-Number: K190282 · 2019-05-24

ApplicantSpectrum Medical , Ltd.
Decision Date2019-05-24
Product CodeDTQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand) is a medical device manufactured by Spectrum Medical , Ltd.. It received FDA 510(k) clearance on 2019-05-24 under approval number K190282. The device is classified under product code DTQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand)?

Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand) is a medical device that received FDA 510(k) clearance on 2019-05-24. It is manufactured by Spectrum Medical , Ltd.. The 510(k) number is K190282.

When was Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand) approved by the FDA?

Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand) received FDA 510(k) clearance on 2019-05-24, under approval number K190282.

What company makes Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand)?

Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand) is manufactured by Spectrum Medical , Ltd..

What is the FDA product code for Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand)?

The FDA product code for Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand) is DTQ.

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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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