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FDA 510(k)

BlueDop Vascular Expert

K-Number: K260700 · 2026-07-08

Decision Date2026-07-08
Product CodeDPW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BlueDop Vascular Expert is the device name listed in this FDA 510(k) record. The listed applicant is BlueDop Medical, Ltd.. It received FDA 510(k) clearance on 2026-07-08 under 510(k) number K260700. The device is classified under product code DPW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BlueDop Vascular Expert?

BlueDop Vascular Expert is a medical device that received FDA 510(k) clearance on 2026-07-08. The listed applicant is BlueDop Medical, Ltd.. The 510(k) number is K260700.

When did BlueDop Vascular Expert receive FDA 510(k) clearance?

BlueDop Vascular Expert received FDA 510(k) clearance on 2026-07-08, under 510(k) number K260700.

Who is the listed applicant for BlueDop Vascular Expert?

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

What is the FDA product code for BlueDop Vascular Expert?

The FDA product code for BlueDop Vascular Expert is DPW.

Related Devices (Code: DPW)

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.

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.