CloverSnare
CloverSnare 4-Loop Vascular Retriever
1manufacturer
1catalogue number
4510(k) clearances naming this product code
1recall
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Lifetech Scientific (Shenzhen) Co,.ltd | Shenzhen | Guangdong | Manufacturer | 3 |
Record
| Listed by | Cook Incorporated, United States |
|---|---|
| FDA product code | MMX |
| Device type | Device, Percutaneous Retrieval |
| Device class | Class 2 |
| Regulation | 21 CFR 870.5150 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-09-24 |
| Record revised | 2021-07-08 (version 3) |
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, manufacturing date |
| Storage | Special storage condition: Store in dark, dry, cool place. |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| G53008 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ONE Snare® | Merit Medical Systems, Inc. | 29 |
| EN Snare® | Merit Medical Systems, Inc. | 17 |
| SeQureTM Snare System | Lifetech Scientific (Shenzhen) Co,.ltd | 12 |
| Expro Elite | Teleflex Medical LLC | 10 |
| Halo™ Single Loop Snare Kit | Argon Medical Devices, Inc. | 9 |
| Atrieve™ Vascular Snare Kit | Argon Medical Devices, Inc. | 7 |
| Halo™ Single-Loop Microsnare Kit | Argon Medical Devices, Inc. | 6 |
| Expro Elite™ snare | Vascular Solutions LLC | 5 |
| Amplatz Goose Neck™ | Medtronic, Inc. | 5 |
| Sympro Elite | Teleflex Medical LLC | 5 |
| Quattro Elite™ snare | Vascular Solutions LLC | 5 |
| Sympro Elite™ snare | Vascular Solutions LLC | 5 |
Showing 12 of 26. All products under Device, Percutaneous Retrieval
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K222254 | 2023-05-16 |
| K181757 | 2018-11-06 |
| K160593 | 2016-09-02 |
| K112185 | 2011-11-02 |
Recalls
1 of these is Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2014-07-17 | Class I | Device Design | This remedial action is the result of six product complaints associated with separation of the snare from the distal tip of the wire. | 696 devices total distribution (671 nationwide) | 2015-06-16 |
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.