Guardian® II Hemostasis Valve
The Guardian hemostasis valves are intended to maintain hemostasis during the use of diagnostic or interventional devices. Guardian hemostasis valves are indicated for maintaining a seal…
The Guardian hemostasis valves are intended to maintain hemostasis during the use of diagnostic or interventional devices. Guardian hemostasis valves are indicated for maintaining a seal around diagnostic/interventional devices with outside diameters up to 8F (0.105″ or 2.67mm) during diagnostic/interventional procedures. The torque device is provided as an aid for steering the guidewire within the vascular anatomy.
Who Else Makes It
Concentrated in Jiangsu (3), Beijing (3), Zhejiang (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai INT Medical Instruments Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Elite Medtek(Jiangsu) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 9 |
| Tianjin Demax Medical Technology Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 5 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Zhejiang Mediunion Healthcare Group Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 105 |
| Joykey Industrial (Pinghu) Limited | Pinghu | Zhejiang | Contract manufacturer | 43 |
| Sunny Medical Device (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
| Tianck Medical Co., Ltd. | Huizhou | Guangdong | Manufacturer | 10 |
| Lepu Medical Technology (Beijing) Co., Ltd. | Beijing | Beijing | Manufacturer | 7 |
| Beijing Target Medical Technologies Inc. | Beijing | Beijing | Contract manufacturer | 7 |
| Beijing Demax Medical Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 5 |
| Curatia Medical Limited | Suzhou | Jiangsu | Specification developer | 5 |
Showing 12 of 13. All 13 manufacturers in China registered for Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Record
| Listed by | Vascular Solutions LLC, United States |
|---|---|
| FDA product code | DTL |
| Device type | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass |
| Device class | Class 2 |
| Regulation | 21 CFR 870.4290 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Record published | 2016-09-06 |
| Record revised | 2023-06-09 (version 6) |
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 |
| Packaging | Box of 25 |
| Distribution end date | 2021-11-22 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8210 | Withdrawn | |
| 8211 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DeRoyal | Deroyal Industries, Inc. | 171 |
| Namic | Medline Industries, Inc. | 170 |
| Namic | Navilyst Medical, Inc. | 165 |
| Merit® Manifold | Merit Medical Systems, Inc. | 119 |
| Connector | LivaNova USA, Inc. | 70 |
| Medline Industries, Inc. | Medline Industries, Inc. | 62 |
| Demax | Beijing Demax Medical Technology Co., Ltd. | 60 |
| DLP® | Medtronic, Inc. | 51 |
| Marquis® Stopcock | Merit Medical Systems, Inc. | 40 |
| Cook | Cook Incorporated | 38 |
| Unbranded | Advance Medical Designs, Inc. | 30 |
| Contrast Line | Argon Medical Devices, Inc. | 25 |
Showing 12 of 127. All products under Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K092563 | 2009-11-04 |
Recalls
2 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2016-03-04 | Class I | Employee error | Vascular Solutions became aware of a potential problem with the click version of the Guardian II hemostasis valves. The low pressure seal may not close properly, which may allow air to be introduced into the device and may lead to risk of | 5283 | 2016-10-19 |
| 2013-02-27 | Class I | Vendor change control | Risk that air may be introduced into the device which may lead to an air embolism. | 79,869 | 2013-08-05 |
| 2012-08-30 | Class II | Process control | Vascular Solutions, Inc., became aware of a potential problem involving pouches missing a seal from Guardian II (Model 8210) and Guardian II NC (Model FH102) Hemostasis Valve which poses a risk of product contamination. | 3500 units | 2012-12-04 |
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.