Vascular Solutions Custom Access Kit
The Custom Access Kit is intended to introduce up to a 0.038”/0.89mm guidewire or catheter into the vascular system following a needle stick.
92manufacturers in China registered for this device type
14catalogue numbers in this listing
13510(k) clearances naming this product code
2recalls on this code
Who Else Makes It
Concentrated in Beijing (28), Guangdong (21), Hebei (13). 11 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jabil Circuit (Shanghai) Ltd. | Shanghai | Shanghai | Contract manufacturer | 31 |
| Sanbor Medical Xiamen, Inc. | Xiamen | Fujian | Contract manufacturer | 16 |
| Beijing Winkonlaser Technology Limited | Beijing | Beijing | Contract manufacturer | 14 |
| Changsha Gomecy Electronics Co., Ltd. | Changsha | Hunan | Contract manufacturer | 9 |
| Gymmax Technology Shenzhen Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Guangzhou Niansheng Beauty Equipment Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 7 |
| Beijing Syntech Laser Co., Ltd. | Beijing | Beijing | Contract manufacturer | 5 |
| VTech Communications Ltd | Dongguan | Guangdong | Contract manufacturer | 5 |
| Wuhan Dimed Laser Technology Co., Ltd. | Wuhan | Hubei | Contract manufacturer | 3 |
| Chengdu Vantron Technology Co., Ltd. | Chengdu | Sichuan | Contract manufacturer | 1 |
| Shanghai Shengguang Science & Technology Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 1 |
| Guilin Woodpecker Medical Instrument Co., Ltd. | Guilin | Guangxi | Manufacturer | 25 |
Showing 12 of 92. All 92 manufacturers in China registered for Powered Laser Surgical Instrument
Record
| Listed by | Vascular Solutions LLC, United States |
|---|---|
| FDA product code | GEX |
| Device type | Powered Laser Surgical Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4810 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Record published | 2016-09-05 |
| Record revised | 2023-06-09 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Sizes | Needle gauge 19 to 21 G; catheter gauge 4 to 5 Fr; length 12 cm |
| Distribution end date | 2021-12-10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 7713 | Needle Gauge 21 G | In distribution |
| 7715 | Needle Gauge 21 G | In distribution |
| 7717 | Needle Gauge 21 G | In distribution |
| 7716 | Needle Gauge 19 G | In distribution |
| 7711 | Needle Gauge 21 G | In distribution |
| 7712 | Needle Gauge 19 G | In distribution |
| 7723 | Needle Gauge 21 G | Withdrawn |
| 7719 | Needle Gauge 21 G | Withdrawn |
| 7718 | Needle Gauge 19 G | Withdrawn |
| 7720 | Needle Gauge 21 G | Withdrawn |
| 7714 | Needle Gauge 19 G | Withdrawn |
| 7710 | Length 12 cm | Withdrawn |
| 7721 | Needle Gauge 19 G | Withdrawn |
| 7722 | Needle Gauge 21 G | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Accu-Beam | Transamerican Technologies International | 181 |
| Powered Laser Surgical Instrument | Weinert Fiber Optics Inc. | 117 |
| Waterlase Laser Tips | Biolase Technology, Inc. | 112 |
| ProFlex™ | Innovaquartz LLC | 109 |
| Dornier MedTech | Dornier Medtech America, Inc. | 91 |
| Powered Laser Surgical Instrument | Ophthalmed LLC | 90 |
| Optilite | Convergent Laser Technologies | 87 |
| Reusable Surgical Optical Fiber | Quanta System Spa | 78 |
| Single use Surgical Optical Fiber | Quanta System Spa | 70 |
| Powered Laser Surgical Instrument | Lutronic Corporation | 57 |
| Waterlase iPlus Dental Laser System | Biolase Technology, Inc. | 53 |
| Leoni™ | Weinert Fiber Optics Inc. | 49 |
Showing 12 of 2,654. All products under Powered Laser Surgical Instrument
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K113140 | 2011-12-22 |
| K093502 | 2010-01-07 |
| K091551 | 2009-06-19 |
| K080104 | 2008-03-26 |
| K072332 | 2008-01-10 |
| K070216 | 2007-03-16 |
| K062822 | 2006-11-21 |
| K051287 | 2005-07-29 |
| K050021 | 2005-03-18 |
| K033237 | 2003-11-20 |
| K032805 | 2003-10-01 |
| K032204 | 2003-08-20 |
| K030654 | 2003-06-18 |
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 |
|---|---|---|---|---|---|
| 2011-01-10 | Not classified | Nonconforming Material/Component | Investigations of a recent Device Experience Report has made us aware of a potential problem with our Vari-Lase WireFiber, Model 7137, manufactured with the following lot numbers: 5500898 and 550896. Recently it was reported that the endov | 41 | 2012-05-03 |
| 2003-10-09 | Not classified | Other | An internal gasket of the Fiber Lock component of the Vari-Lase Kit contains natural rubber latex, but the product labeling does not recognize the presence of latex and include the required cautionary statement. | 390 kits | 2005-11-21 |
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.