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510(k) K260700

BlueDop Vascular Expert by BlueDop Medical, Ltd. — Product Code DPW

K260700 is an FDA 510(k) premarket notification submitted by BlueDop Medical, Ltd. for the device "BlueDop Vascular Expert". The FDA issued a decision of Substantially Equivalent on July 8, 2026. The device falls under product code DPW (Flowmeter, Blood, Cardiovascular), a Class II device regulated under 21 CFR 870.2100.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 2026
Date Received
March 4, 2026
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Flowmeter, Blood, Cardiovascular
Device Class
Class II
Regulation Number
870.2100
Review Panel
CV
Submission Type

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FDA data resources