510(k) K222533

Device
Target Tetra Detachable Coils
Applicant
Stryker Neurovascular
510(k) number
K222533
Product code
HCG
Decision
Substantially Equivalent (SESE)
Decision date
2022-12-14
Date received
2022-08-22
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
No

Related Records

Applicant Contact

Contact
Jonathan Bemben
Address
47900 Bayside Pkwy. Fremont CA US 94538 94538

FDA Registration Numbers

Source Documents

510(k) summary PDF

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