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FDA 510(k)

HeartSpan Steerable Sheath Introducer

K-Number: K170668 · 2017-04-05

ApplicantMerit Medical Systems, Inc.
Decision Date2017-04-05
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HeartSpan Steerable Sheath Introducer is a medical device manufactured by Merit Medical Systems, Inc.. It received FDA 510(k) clearance on 2017-04-05 under approval number K170668. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HeartSpan Steerable Sheath Introducer?

HeartSpan Steerable Sheath Introducer is a medical device that received FDA 510(k) clearance on 2017-04-05. It is manufactured by Merit Medical Systems, Inc.. The 510(k) number is K170668.

When was HeartSpan Steerable Sheath Introducer approved by the FDA?

HeartSpan Steerable Sheath Introducer received FDA 510(k) clearance on 2017-04-05, under approval number K170668.

What company makes HeartSpan Steerable Sheath Introducer?

HeartSpan Steerable Sheath Introducer is manufactured by Merit Medical Systems, Inc..

What is the FDA product code for HeartSpan Steerable Sheath Introducer?

The FDA product code for HeartSpan Steerable Sheath Introducer is DYB.

Related Clinical Trials

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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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