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FDA 510(k)

35 Helix Guidewire

K-Number: K260751 · 2026-08-27

ApplicantPiraeus Medical, Inc.
Decision Date2026-08-27
Product CodeMOF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

35 Helix Guidewire is the device name listed in this FDA 510(k) record. The listed applicant is Piraeus Medical, Inc.. It received FDA 510(k) clearance on 2026-08-27 under 510(k) number K260751. 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 35 Helix Guidewire?

35 Helix Guidewire is a medical device that received FDA 510(k) clearance on 2026-08-27. The listed applicant is Piraeus Medical, Inc.. The 510(k) number is K260751.

When did 35 Helix Guidewire receive FDA 510(k) clearance?

35 Helix Guidewire received FDA 510(k) clearance on 2026-08-27, under 510(k) number K260751.

Who is the listed applicant for 35 Helix Guidewire?

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

What is the FDA product code for 35 Helix Guidewire?

The FDA product code for 35 Helix Guidewire is MOF.

Other records listing Piraeus Medical, Inc. 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.

K25104493 NeuFlex CatheterK24097187 NeuGlide Catheter

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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