Penumbra Coil 400
Penumbra Coil 400 is an implantable embolisation coil used in intracranial aneurysms, other neurovascular abnormalities and peripheral arterial or venous embolisation. Its neurovascular…
Penumbra Coil 400 is an implantable embolisation coil used in intracranial aneurysms, other neurovascular abnormalities and peripheral arterial or venous embolisation. Its neurovascular indications include arteriovenous malformations and fistulae.
The coil is attached to a stainless-steel and polymer delivery pusher and is released using a separate detachment handle. The coil system includes different shapes, diameters and softness configurations, including an extra-soft coil option.
Listed Item
Coil 400 Extra Soft, 6mm x 10cm
Supply
Embolisation coils are sterile, non-pyrogenic and intended for a single use. The detachment handle may detach multiple coils during one patient procedure and is a separate component.
5manufacturers in China registered for this device type
268catalogue numbers in this listing
10510(k) clearances naming this product code
1recall
Who Else Makes It
Concentrated in Jiangsu (2), Shanghai (2), Guangdong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Shanghai Wallaby Medical Technologies Co., Inc. | Shanghai | Shanghai | Contract manufacturer | 5 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Suzhou Prosteri Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 20 |
| Microport Neurotech (Shanghai) Co., Ltd. | Shanghai | Shanghai | Manufacturer | 2 |
Record
| Listed by | Penumbra Inc., United States |
|---|---|
| FDA product code | HCG |
| Device type | Device, Neurovascular Embolization |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5950 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K103305 |
| Record published | 2016-07-30 |
| Record revised | 2026-07-14 (version 4) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, serial number |
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Showing 250 of 268 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Optima Coil System | Balt USA, LLC | 307 |
| Smart Coil | Penumbra Inc. | 238 |
| Axium™ Detachable Coil System | Micro Therapeutics, Inc. | 234 |
| Numen | Microport Neurotech (Shanghai) Co., Ltd. | 223 |
| Axium™ Prime Detachable Coil System | Micro Therapeutics, Inc. | 141 |
| Barricade Coil System | Balt USA, LLC | 137 |
| Numen Helia | Microport Neurotech (Shanghai) Co., Ltd. | 129 |
| V-Trak | MicroVention, Inc. | 106 |
| HydroSoft Helical | MicroVention, Inc. | 94 |
| AxiumTM | Micro Therapeutics, Inc. | 89 |
| LP Coil System | Penumbra Inc. | 77 |
| Trufill DCS Orbit | Cerenovus, Inc. | 74 |
Showing 12 of 99. All products under Device, Neurovascular Embolization
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K230284 | 2023-10-25 |
| K192955 | 2019-11-20 |
| K173614 | 2018-04-17 |
| K170852 | 2017-07-19 |
| K160832 | 2016-04-20 |
| K151572 | 2015-07-10 |
| K143218 | 2015-03-18 |
| K141134 | 2014-07-03 |
| K120330 | 2012-04-02 |
| K103305 | 2011-01-26 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Penumbra Inc. | 510(k) number | 2011-03-04 | Not classified | Process change control | The diameter of a component of the device is out of tolerance specification; the Delivery Pusher pull wire which secures the coil in place can prolapse and allow premature detachment of the coil. | 2082 | 2011-06-06 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.