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FDA 510(k)

Guider Catheter Introducer

K-Number: K171081 · 2017-05-09

ApplicantRhythm Xience, Inc. (Rxi)
Decision Date2017-05-09
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Guider Catheter Introducer is the device name listed in this FDA 510(k) record. The listed applicant is Rhythm Xience, Inc. (Rxi). It received FDA 510(k) clearance on 2017-05-09 under 510(k) number K171081. 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 Guider Catheter Introducer?

Guider Catheter Introducer is a medical device that received FDA 510(k) clearance on 2017-05-09. The listed applicant is Rhythm Xience, Inc. (Rxi). The 510(k) number is K171081.

When did Guider Catheter Introducer receive FDA 510(k) clearance?

Guider Catheter Introducer received FDA 510(k) clearance on 2017-05-09, under 510(k) number K171081.

Who is the listed applicant for Guider Catheter Introducer?

The FDA 510(k) record lists Rhythm Xience, Inc. (Rxi) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Guider Catheter Introducer?

The FDA product code for Guider Catheter Introducer is DYB.

Other records listing Rhythm Xience, Inc. (Rxi) as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K170373Flextra Steerable Introducer

Related Devices (Code: DYB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253526NAMIC Dilator and SheathMedline Industries, LPK261529Micropuncture 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, LLCK261242SimplGuidePendracareK261950Health Line Tearaway IntroducerHealth Line International CorporationK261492FieldFlex Steerable SheathCenterPoint Systems, LLCK260606Echo Large Bore Introducer SheathEcho Medical, LLC

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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