Penumbra Coil System/Penumbra Coil 400
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K120330 FDA 510(k)
- FDA Product Code
- HCG FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.5950 FDA 510(k)
- Regulation Number
- 882.5950 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Penumbra Coil System/Penumbra Coil 400 is a neurovascular embolization device designed for occlusion of blood vessels. It functions by preventing blood flow to specific areas, aiding in the treatment of conditions such as aneurysms.
The device is supplied as a .020″ (.508 mm) primary diameter platinum coil intended for use in neurovascular embolization procedures. It is a single-use device regulated under FDA 510(k) clearance (K120330) and classified as a Class II medical device under regulation number 882.5950.
Frequently asked questions
What is the Penumbra Coil System/Penumbra Coil 400 used for?
The Penumbra Coil System/Penumbra Coil 400 is designed for occlusion of blood vessels in neurovascular embolization procedures, preventing blood flow to specific areas to aid in treating conditions such as aneurysms.
How is the Penumbra Coil System/Penumbra Coil 400 supplied and is it reusable?
The device is supplied as a .020″ (.508 mm) primary diameter platinum coil and is intended for single-use only, meaning it must not be reused after a procedure to ensure patient safety and device integrity.
What regulatory pathway was used for the Penumbra Coil System/Penumbra Coil 400?
The Penumbra Coil System/Penumbra Coil 400 received FDA 510(k) clearance under submission number K120330 and is classified as a Class II medical device under regulation number 882.5950.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PC400 System - Penumbra Inc, PC400 System - Penumbra Inc, Penumbra Coil System Penumbra Coil 400 - Penumbra | FDA Evidence Review, DeviceMD - PC400™ System
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K120330 | Class II | Active |
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Manufacturer
- Manufacturer
- Penumbra, Inc.
Sources (1)
- FDA 510(k) K120330 24 fields · synced Sep 28, 2026