Penumbra System
Coil Detachment Handle
5manufacturers in China registered for this device type
4catalogue 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) | K141134 |
| Record published | 2016-07-30 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PODH1 | In distribution | |
| SCH1 | In distribution | |
| RH1-A | In distribution | |
| DH1 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Optima Coil System | Balt USA, LLC | 307 |
| Penumbra Coil 400 | Penumbra Inc. | 268 |
| 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 |
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.