Biosensors Embolectomy Catheter
16 catalogue numbers from EL 1780 (VP CAP), listed by Bioptimal International Pte. Ltd., Singapore, under Catheter, Embolectomy. 1 manufacturer in China is registered for this product code.
1manufacturer
16catalogue numbers in this listing
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 | Bioptimal International Pte. Ltd., Singapore |
|---|---|
| FDA product code | DXE |
| Device type | Catheter, Embolectomy |
| Device class | Class 2 |
| Regulation | 21 CFR 870.5150 |
| Establishment | Manufacturer |
| Record published | 2020-10-01 |
| Record revised | 2022-10-24 (version 6) |
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 cool dry places |
| Packaging | Carton of 30, carton of 60 |
| Distribution end date | 2020-12-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EL 1780 (VP CAP) | In distribution | |
| EL3260 | In distribution | |
| EL 1480 (VP CAP) | In distribution | |
| EL 1580 (VP CAP) | In distribution | |
| EL3280 | In distribution | |
| EL 1680 (VP CAP) | In distribution | |
| EL3380 | In distribution | |
| EL1440 (VP CAP) | In distribution | |
| EL 1580 (VP CAP) | Withdrawn | |
| EL1440 (VP CAP) | Withdrawn | |
| EL 1480 (VP CAP) | Withdrawn | |
| EL3280 | Withdrawn | |
| EL3260 | Withdrawn | |
| EL 1680 (VP CAP) | Withdrawn | |
| EL3380 | Withdrawn | |
| EL 1780 (VP CAP) | Withdrawn |
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 |
| 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 |
| Syntel Silicone OTW Embolectomy Catheter | Lemaitre Vascular, Inc. | 9 |
Showing 12 of 88. All products under Catheter, Embolectomy
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.