FDA 510(k)

HeartSpan Steerable Sheath Introducer

K-Number: K170668 · 2017-04-05

Decision Date2017-04-05

Product CodeDYB

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

HeartSpan Steerable Sheath Introducer is the device name listed in this FDA 510(k) record. The listed applicant is Merit Medical Systems, Inc.. It received FDA 510(k) clearance on 2017-04-05 under 510(k) 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. The listed applicant is Merit Medical Systems, Inc.. The 510(k) number is K170668.

When did HeartSpan Steerable Sheath Introducer receive FDA 510(k) clearance?

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

Who is the listed applicant for HeartSpan Steerable Sheath Introducer?

The FDA 510(k) record lists Merit Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

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Related Devices (Code: DYB)

K253526NAMIC Dilator and SheathMedline Industries, LP K261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04)Hartman Medical Group, LLC K261242SimplGuidePendracare K261950Health Line Tearaway IntroducerHealth Line International Corporation K261492FieldFlex Steerable SheathCenterPoint Systems, LLC K260606Echo Large Bore Introducer SheathEcho Medical, LLC

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.