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FDA 510(k)

Steerable Introducer

K-Number: K191190 · 2019-08-01

ApplicantFreudenberg Medical, LLC
Decision Date2019-08-01
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Steerable Introducer is the device name listed in this FDA 510(k) record. The listed applicant is Freudenberg Medical, LLC. It received FDA 510(k) clearance on 2019-08-01 under 510(k) number K191190. 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 Steerable Introducer?

Steerable Introducer is a medical device that received FDA 510(k) clearance on 2019-08-01. The listed applicant is Freudenberg Medical, LLC. The 510(k) number is K191190.

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

Steerable Introducer received FDA 510(k) clearance on 2019-08-01, under 510(k) number K191190.

Who is the listed applicant for Steerable Introducer?

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

What is the FDA product code for Steerable Introducer?

The FDA product code for Steerable Introducer is DYB.

Related Clinical Trials

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.

NCT06106594VOLT CE Mark StudyACTIVE_NOT_RECRUITINGNCT06223789VOLT-AF IDE Clinical StudyCOMPLETED

Other records listing Freudenberg Medical, LLC 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.

K240763FirstFit Surgical KitK192422Steerable Introducer 12F

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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