FDA.report

510(k) K251789

Device
EMBOTRAP III Revascularization Device
Applicant
Neuravi Limited
510(k) number
K251789
Product code
NRY
Decision
Substantially Equivalent (SESE)
Decision date
2025-09-25
Date received
2025-06-11
Regulation
870.1250
Classification name
Catheter, Thrombus Retriever
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Marie Seoighe
Address
Block 3, Ballybrit Business Park Galway IE H91 K5YD H91 K5YD

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

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K251015APRO 45 Catheter and Alembic Aspiration TubingAlembic, LLC2025-04-30
K250958APRO 55 Swift Catheter and Alembic Aspiration TubingAlembic, LLC2025-04-28
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