Smart Coil
Penumbra Smart Coil places embolization coils in selected blood vessels. A sufficient quantity of bare platinum coils packs the target segment to achieve occlusion. The delivery assembly…
Penumbra Smart Coil places embolization coils in selected blood vessels. A sufficient quantity of bare platinum coils packs the target segment to achieve occlusion.
The delivery assembly combines a coil implant, detachment pusher and detachment handle. Ruby LP and Finish LP are related line-extension configurations using the Smart Coil sheath, pusher and handle platform.
Listed Item
Ruby Coil LP, 4mm x 10cm
LP Delivery Components
In the LP configuration, a radiopaque positioning marker sits on the pusher, which also contains a distal detachment tip and pull wire. A separately packaged handle detaches the coil from the pusher. The listed Ruby Coil LP is one configuration within this broader coil family.
5manufacturers in China registered for this device type
238catalogue 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) | K143218 |
| Record published | 2016-07-30 |
| Record revised | 2026-07-17 (version 5) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| 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 |
|---|---|---|
| 400SMTXSFT1H02 | In distribution | |
| 400SMTSFT1045 | In distribution | |
| 400SMTXSFT0205 | In distribution | |
| 400SMTXSFT0210 | In distribution | |
| 400SMTSTD0825 | In distribution | |
| 400SMTSTD1030 | In distribution | |
| 400SMTXSFT4H12 | In distribution | |
| 400SMTSTD0820 | In distribution | |
| 400SMTXSFT0410 | In distribution | |
| 400SMTSTD1135 | In distribution | |
| 400SMTHXSFT0404 | In distribution | |
| 400SMTSTD0935 | In distribution | |
| 400SMTHXSFT0105 | In distribution | |
| 400SMTSFT0620 | In distribution | |
| 400SMTSFT0815 | In distribution | |
| 400SMTSFT0308 | In distribution | |
| 400SMTHXSFT0308 | In distribution | |
| 400SMTSTD0520 | In distribution | |
| 400SMTSTD0515 | In distribution | |
| 400SMTSTD0610 | In distribution | |
| 400SMTXSFT0412 | In distribution | |
| 400SMTSTD0410 | In distribution | |
| 400SMTSTD1045 | In distribution | |
| 400SMTSFT0610 | In distribution | |
| 400SMTSTD1860 | In distribution | |
| 400SMTHXSFT0102 | In distribution | |
| 400SMTXSFT0515 | In distribution | |
| 400SMTHXSFT0406 | In distribution | |
| 400SMTSFT0406 | In distribution | |
| 400SMTSTD0945 | In distribution | |
| 400SMTXSFT3H12 | In distribution | |
| 400SMTHXSFT0203 | In distribution | |
| 400SMTHXSFT0415 | In distribution | |
| 400SMTSFT0304 | In distribution | |
| 400SMTXSFT4H20 | In distribution | |
| 400SMTHXSFT3H15 | In distribution | |
| 400SMTSFT4H08 | In distribution | |
| 400SMTSTD1660 | In distribution | |
| 400SMTXSFT1H1H | In distribution | |
| 400SMTSTD0406 | In distribution | |
| 400SMTHXSFT4H10 | In distribution | |
| 400SMTSFT3H04 | In distribution | |
| 400SMTXSFT0408 | In distribution | |
| 400SMTHXSFT3H10 | In distribution | |
| 400SMTHXSFT0101 | In distribution | |
| 400SMTSTD0415 | In distribution | |
| 400SMTSFT1145 | In distribution | |
| 400SMTSFT0202 | In distribution | |
| 400SMTXSFT0208 | In distribution | |
| 400SMTSTD4H15 | In distribution | |
| 400SMTHXSFT0620 | In distribution | |
| 400SMTHXSFT0306 | In distribution | |
| 400SMTSFT1130 | In distribution | |
| 400SMTXSFT0202 | In distribution | |
| 400SMTSFT0720 | In distribution | |
| 400SMTSTD0830 | In distribution | |
| 400SMTHXSFT0201 | In distribution | |
| 400SMTHXSFT0209 | In distribution | |
| 400SMTXSFT4H06 | In distribution | |
| 400SMTSTD0620 | In distribution | |
| 400SMTXSFT2H07 | In distribution | |
| 400SMTHXSFT1H05 | In distribution | |
| 400SMTXSFT0615 | In distribution | |
| 400SMTXSFT1H06 | In distribution | |
| RBYLP0410 | In distribution | |
| 400SMTSFT0930 | In distribution | |
| 400SMTXSFT4H08 | In distribution | |
| 400SMTSTD3H05 | In distribution | |
| 400SMTHXSFT1H01 | In distribution | |
| 400SMTSFT1030 | In distribution | |
| 400SMTXSFT0404 | In distribution | |
| 400SMTSTD0835 | In distribution | |
| 400SMTSTD1560 | In distribution | |
| 400SMTXSFT0310 | In distribution | |
| 400SMTSTD1260 | In distribution | |
| 400SMTSTD0304 | In distribution | |
| 400SMTHXSFT4H06 | In distribution | |
| 400SMTSFT0608 | In distribution | |
| 400SMTSFT4H10 | In distribution | |
| 400SMTSTD1235 | In distribution | |
| 400SMTHXSFT0515 | In distribution | |
| 400SMTXSFT0201 | In distribution | |
| 400SMTXSFT0306 | In distribution | |
| 400SMTSTD0510 | In distribution | |
| 400SMTXSFT0105 | In distribution | |
| 400SMTHXSFT1H04 | In distribution | |
| 400SMTSFT0920 | In distribution | |
| 400SMTSTD0412 | In distribution | |
| 400SMTXSFT2H08 | In distribution | |
| 400SMTHXSFT3H06 | In distribution | |
| 400SMTHXSFT0207 | In distribution | |
| 400SMTSTD1360 | In distribution | |
| 400SMTSFT4H12 | In distribution | |
| 400SMTXSFT0204 | In distribution | |
| 400SMTHXSFT2H10 | In distribution | |
| 400SMTSTD4H08 | In distribution | |
| 400SMTSFT0506 | In distribution | |
| 400SMTSFT0310 | In distribution | |
| 400SMTSTD0720 | In distribution | |
| 400SMTHXSFT0412 | In distribution | |
| 400SMTXSFT0101 | In distribution | |
| 400SMTSFT0915 | In distribution | |
| 400SMTSTD0730 | In distribution | |
| 400SMTXSFT011H | In distribution | |
| 400SMTSTD3H08 | In distribution | |
| 400SMTHXSFT2H09 | In distribution | |
| 400SMTSFT0820 | In distribution | |
| 400SMTHXSFT1H03 | In distribution | |
| 400SMTHXSFT011H | In distribution | |
| 400SMTSTD1460 | In distribution | |
| 400SMTSFT4H20 | In distribution | |
| 400SMTHXSFT4H15 | In distribution | |
| 400SMTHXSFT0103 | In distribution | |
| 400SMTHXSFT0408 | In distribution | |
| 400SMTHXSFT0206 | In distribution | |
| 400SMTSFT1020 | In distribution | |
| 400SMTHXSFT0310 | In distribution | |
| 400SMTSTD0306 | In distribution | |
| 400SMTXSFT0304 | In distribution | |
| 400SMTHXSFT0303 | In distribution | |
| 400SMTHXSFT2H06 | In distribution | |
| 400SMTSFT0408 | In distribution | |
| 400SMTXSFT0415 | In distribution | |
| 400SMTSTD1145 | In distribution | |
| 400SMTXSFT2H02 | In distribution | |
| 400SMTXSFT2H03 | In distribution | |
| 400SMTHXSFT0205 | In distribution | |
| 400SMTSTD4H10 | In distribution | |
| 400SMTSFT3H10 | In distribution | |
| 400SMTSFT0508 | In distribution | |
| 400SMTSFT0203 | In distribution | |
| 400SMTHXSFT3H04 | In distribution | |
| 400SMTSTD0408 | In distribution | |
| 400SMTXSFT1H01 | In distribution | |
| 400SMTSTD1345 | In distribution | |
| 400SMTXSFT0207 | In distribution | |
| 400SMTHXSFT0610 | In distribution | |
| 400SMTHXSFT0520 | In distribution | |
| 400SMTXSFT0104 | In distribution | |
| 400SMTSTD0508 | In distribution | |
| 400SMTSFT2H05 | In distribution | |
| 400SMTXSFT0620 | In distribution | |
| 400SMTSFT1445 | In distribution | |
| 400SMTSFT3H06 | In distribution | |
| 400SMTHXSFT4H20 | In distribution | |
| 400SMTSFT1345 | In distribution | |
| 400SMTSFT0730 | In distribution | |
| 400SMTXSFT0520 | In distribution | |
| 400SMTSFT2H03 | In distribution | |
| 400SMTHXSFT0208 | In distribution | |
| 400SMTXSFT0510 | In distribution | |
| 400SMTSFT0204 | In distribution | |
| 400SMTHXSFT1H06 | In distribution | |
| 400SMTXSFT0308 | In distribution | |
| 400SMTHXSFT0615 | In distribution | |
| 400SMTSTD0725 | In distribution | |
| 400SMTSTD4H20 | In distribution | |
| 400SMTHXSFT1H1H | In distribution | |
| 400SMTSTD0925 | In distribution | |
| 400SMTXSFT3H08 | In distribution | |
| 400SMTXSFT3H04 | In distribution | |
| 400SMTSFT2H04 | In distribution | |
| 400SMTSTD1645 | In distribution | |
| 400SMTHXSFT1H02 | In distribution | |
| 400SMTHXSFT4H12 | In distribution | |
| 400SMTXSFT0102 | In distribution | |
| 400SMTXSFT0303 | In distribution | |
| 400SMTXSFT2H09 | In distribution | |
| 400SMTXSFT4H10 | In distribution | |
| 400SMTHXSFT0104 | In distribution | |
| 400SMTXSFT1H03 | In distribution | |
| 400SMTSFT3H08 | In distribution | |
| 400SMTHXSFT0202 | In distribution | |
| 400SMTHXSFT2H04 | In distribution | |
| 400SMTXSFT3H10 | In distribution | |
| 400SMTSTD0305 | In distribution | |
| 400SMTXSFT3H15 | In distribution | |
| 400SMTSTD3H06 | In distribution | |
| 400SMTHXSFT0410 | In distribution | |
| 400SMTXSFT2H04 | In distribution | |
| 400SMTSTD0420 | In distribution | |
| 400SMTXSFT3H06 | In distribution | |
| 400SMTHXSFT0204 | In distribution | |
| 400SMTSFT0615 | In distribution | |
| 400SMTSFT0412 | In distribution | |
| 400SMTXSFT0206 | In distribution | |
| 400SMTXSFT0209 | In distribution | |
| 400SMTXSFT0406 | In distribution | |
| 400SMTSTD0715 | In distribution | |
| 400SMTSFT1330 | In distribution | |
| 400SMTHXSFT0210 | In distribution | |
| 400SMTSFT1245 | In distribution | |
| 400SMTHXSFT0510 | In distribution | |
| 400SMTSTD1445 | In distribution | |
| 400SMTHXSFT3H12 | In distribution | |
| 400SMTSFT1230 | In distribution | |
| 400SMTSFT0415 | In distribution | |
| 400SMTSFT0420 | In distribution | |
| 400SMTSFT0306 | In distribution | |
| 400SMTSFT0510 | In distribution | |
| 400SMTSTD1845 | In distribution | |
| 400SMTHXSFT0304 | In distribution | |
| 400SMTSFT1430 | In distribution | |
| 400SMTXSFT0203 | In distribution | |
| 400SMTSTD1545 | In distribution | |
| 400SMTHXSFT4H08 | In distribution | |
| 400SMTHXSFT0420 | In distribution | |
| 400SMTSTD1245 | In distribution | |
| 400SMTXSFT2H06 | In distribution | |
| 400SMTXSFT1H04 | In distribution | |
| 400SMTHXSFT3H08 | In distribution | |
| 400SMTXSFT1H05 | In distribution | |
| 400SMTSFT0830 | In distribution | |
| 400SMTSFT0715 | In distribution | |
| 400SMTSTD3H10 | In distribution | |
| 400SMTSTD0920 | In distribution | |
| 400SMTSFT4H15 | In distribution | |
| 400SMTSTD0930 | In distribution | |
| 400SMTSFT4H06 | In distribution | |
| 400SMTSTD4H06 | In distribution | |
| 400SMTXSFT4H15 | In distribution | |
| 400SMTSTD1160 | In distribution | |
| 400SMTSFT0710 | In distribution | |
| 400SMTHXSFT2H08 | In distribution | |
| 400SMTHXSFT2H02 | In distribution | |
| 400SMTSFT0515 | In distribution | |
| 400SMTXSFT2H10 | In distribution | |
| 400SMTXSFT0610 | In distribution | |
| 400SMTHXSFT2H07 | In distribution | |
| 400SMTHXSFT2H03 | In distribution | |
| 400SMTSFT0520 | In distribution | |
| 400SMTSTD4H12 | In distribution | |
| 400SMTSTD0615 | In distribution | |
| 400SMTXSFT0420 | In distribution | |
| 400SMTSFT0410 | In distribution | |
| 400SMTSTD0625 | In distribution | |
| 400SMTXSFT0103 | In distribution | |
| 400SMTSFT2H06 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Optima Coil System | Balt USA, LLC | 307 |
| Penumbra Coil 400 | Penumbra Inc. | 268 |
| 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
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 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.