510(k) K252694

Device
Target Detachable Coil
Applicant
Stryker Neurovascular
510(k) number
K252694
Product code
HCG
Decision
Substantially Equivalent (SESE)
Decision date
2025-12-11
Date received
2025-08-26
Regulation
882.5950
Classification name
Device, Neurovascular Embolization
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Genae Tripp
Address
47900 Bayside Pkwy. Fremont CA US 94538 94538

FDA Registration Numbers

Source Documents

510(k) summary PDF

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