Stryker Interventional Spine iVAS™ Inflator
Inflation Device: 14mL, 30atm
4manufacturers in China registered for this device type
1catalogue number
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (2), Zhejiang (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
| Zhejiang Chuangxiang Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Jiana Sterilization Technology (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 23 |
| Seplou (Zhuhai) Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 7 |
Record
| Listed by | Atrion Medical Products, Inc., United States |
|---|---|
| FDA product code | KOE |
| Device type | Dilator, Urethral |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5520 |
| Establishment | Contract manufacturer, Manufacturer |
| Record published | 2016-09-20 |
| Record revised | 2020-09-03 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| QL® 1430 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cook | Cook Incorporated | 96 |
| Amplatz | Cook Incorporated | 66 |
| Wellead Urethral Dilator | Well Lead Medical Co., Ltd. | 17 |
| UroMax Ultra Kit | Boston Scientific Corporation | 16 |
| Peel-Away | Cook Incorporated | 15 |
| Dilator, Urethral | Richard Wolf Gmbh | 15 |
| V. Mueller | Steris Corporation | 14 |
| EZDilate | Gyrus Acmi, Inc. | 11 |
| QL Disposable Inflation Device | Atrion Medical Products, Inc. | 11 |
| UroMax Ultra | Boston Scientific Corporation | 11 |
| Flexor | Cook Incorporated | 10 |
| Seplou | Seplou (Zhuhai) Co., Ltd. | 6 |
Showing 12 of 49. All products under Dilator, Urethral
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K032840 | 2004-03-03 |
| K972964 | 1997-10-10 |
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.