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FDA 510(k)

HYBRID Guidewire

K-Number: K182337 · 2018-10-04

ApplicantBalt USA, LLC
Decision Date2018-10-04
Product CodeMOF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HYBRID Guidewire is the device name listed in this FDA 510(k) record. The listed applicant is Balt USA, LLC. It received FDA 510(k) clearance on 2018-10-04 under 510(k) number K182337. The device is classified under product code MOF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYBRID Guidewire?

HYBRID Guidewire is a medical device that received FDA 510(k) clearance on 2018-10-04. The listed applicant is Balt USA, LLC. The 510(k) number is K182337.

When did HYBRID Guidewire receive FDA 510(k) clearance?

HYBRID Guidewire received FDA 510(k) clearance on 2018-10-04, under 510(k) number K182337.

Who is the listed applicant for HYBRID Guidewire?

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

What is the FDA product code for HYBRID Guidewire?

The FDA product code for HYBRID Guidewire is MOF.

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Other records listing Balt USA, LLC as applicant

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Related Devices (Code: MOF)

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.

K262424Willow 12 GuidewireArbor Endovascular, LLCK260223Aristotle Mini GuidewireScientia Vascular, Inc.K254006Drivewire 35 GuidewireRapid Medical Ltd.K253579Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 GuidewireScientia Vascular, Inc.K252317Zenith Micro GuidewireSuzhou Zenith Vascular SciTech LimitedK260537Willow 24 GuidewireArbor Endovascular, 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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