FDA PMA

Intracranial coil-assist stent

PMA Number: P180031 · 2025-06-24

ApplicantStryker Neurovascular

Decision Date2025-06-24

PMA NumberP180031

Product CodeQCA

Device ClassClass 3

Medical SpecialtyU

Advisory CommitteeNE

Device Summary

Intracranial coil-assist stent is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Neurovascular. It received FDA 510(k) clearance on 2025-06-24. The device is classified under product code QCA. It was reviewed by the NE advisory panel.

Frequently Asked Questions

What is the Intracranial coil-assist stent?

Intracranial coil-assist stent is a medical device that received FDA 510(k) clearance on 2025-06-24. The listed applicant is Stryker Neurovascular.

When did Intracranial coil-assist stent receive FDA 510(k) clearance?

The clearance date for Intracranial coil-assist stent can be found in the official FDA records.

Who is the listed applicant for Intracranial coil-assist stent?

The FDA 510(k) record lists Stryker Neurovascular as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Intracranial coil-assist stent?

The FDA product code for Intracranial coil-assist stent is QCA.

Related Clinical Trials

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.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.