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FDA 510(k)

THE SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER

K-Number: K100819 · 2010-08-02

ApplicantOnset Medical Corporation
Decision Date2010-08-02
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

THE SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER is the device name listed in this FDA 510(k) record. The listed applicant is Onset Medical Corporation. It received FDA 510(k) clearance on 2010-08-02 under 510(k) number K100819. 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 THE SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER?

THE SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER is a medical device that received FDA 510(k) clearance on 2010-08-02. The listed applicant is Onset Medical Corporation. The 510(k) number is K100819.

When did THE SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER receive FDA 510(k) clearance?

THE SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER received FDA 510(k) clearance on 2010-08-02, under 510(k) number K100819.

Who is the listed applicant for THE SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER?

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

What is the FDA product code for THE SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER?

The FDA product code for THE SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER is DYB.

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Other records listing Onset Medical Corporation 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.

K152498SoloPath Re-Collapsible Access SystemK121404SOLOPATH RE-COLLAPSIBLE ACCESS SYSTEMK112629ONSET ACCESS CATHETER SYSTEMK092014SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCERK062852BALLOON EXPANDABLE TRANSSEPTAL INDRODUCER, MODELS BETI-1840 AND BETI-1870K061009PATHWAY BALLOON EXPANDABLE URETERAL ACCESS SHEATH, MODEL BEUS

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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

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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