Bard
Embolectomy Catheter and Syringe
1manufacturer
1catalogue number
4510(k) clearances naming this product code
4recalls on this code
Who Else Makes It
Registered in Shandong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Bioxin Medical Co., Ltd. | Weihai | Shandong | Contract manufacturer | 8 |
Record
| Listed by | Applied Medical Resources Corp., United States |
|---|---|
| FDA product code | DXE |
| Device type | Catheter, Embolectomy |
| Device class | Class 2 |
| Regulation | 21 CFR 870.5150 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer |
| Record published | 2016-09-24 |
| Record revised | 2022-10-24 (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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CE0340DR | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| LeMaitre Embolectomy Catheter | Lemaitre Vascular, Inc. | 68 |
| LMI Arterial Embolectomy Catheter | Lucas Medical, Inc. | 63 |
| Indigo System | Penumbra Inc. | 60 |
| Fogarty | Edwards Lifesciences Technology Sarl | 44 |
| Arrow | Teleflex Medical LLC | 28 |
| Bard Latex-free Arterial Embolectomy Catheters | Applied Medical Resources Corp. | 22 |
| Biosensors Embolectomy Catheter | Bioptimal International Pte. Ltd. | 16 |
| Amplatz Goose Neck | Covidien LP | 15 |
| Amplatz Goose Neck™ | ev3, Inc. | 13 |
| LMI Thrombectomy Catheter | Lucas Medical, Inc. | 12 |
| LMI Occlusion Catheter | Lucas Medical, Inc. | 12 |
| Syntel Thrombectomy Catheter | Applied Medical Resources Corp. | 9 |
Showing 12 of 88. All products under Catheter, Embolectomy
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K202049 | 2021-09-07 |
| K973465 | 1998-02-19 |
| K970762 | 1997-03-28 |
| K950586 | 1995-05-15 |
Recalls
3 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 |
|---|---|---|---|---|---|
| 2019-10-24 | Class I | Component change control | The firm has received reports of tip separation during usage of the catheters, which may expose patients to unintended dislodgement of the tip from the body of the catheter. | 28,799 catheters in total | 2023-06-01 |
| 2019-10-24 | Class I | Component change control | The firm has received reports of tip separation during usage of the catheters, which may expose patients to unintended dislodgement of the tip from the body of the catheter. | 28,799 catheters in total | 2023-06-01 |
| 2019-10-24 | Class I | Component change control | The firm has received reports of tip separation during usage of the catheters, which may expose patients to unintended dislodgement of the tip from the body of the catheter. | 28,799 catheters in total | 2023-06-01 |
| 2012-08-09 | Class II | Material/Component Contamination | Applied Medical is recalling specific lot numbers of its Vascular Catheters because they may have a potential for packaging particulate matter to reside on the product. | 40,238 units for all products in Recall Event | 2013-03-22 |
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.