LMI Arterial Embolectomy Catheter
63 catalogue numbers from NL4EMB100, listed by Lucas Medical, Inc., United States, under Catheter, Embolectomy. 1 manufacturer in China is registered for this product code.
1manufacturer
63catalogue numbers in this listing
4510(k) clearances naming this product 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 | Lucas Medical, Inc., United States |
|---|---|
| FDA product code | DXE |
| Device type | Catheter, Embolectomy |
| Device class | Class 2 |
| Regulation | 21 CFR 870.5150 |
| Establishment | Manufacturer |
| 510(k) | K954760 |
| Record published | 2016-10-19 |
| Record revised | 2022-10-24 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| NL4EMB100 | In distribution | |
| NL5EMB80T | In distribution | |
| NL6EMB80 | In distribution | |
| NL5EMB40T | In distribution | |
| 6FEMB80 | In distribution | |
| 2FEMB60 | In distribution | |
| NL3FEMB40 | In distribution | |
| NL7FEMB40 | In distribution | |
| NL5FEMB40 | In distribution | |
| NL3EMB40 | In distribution | |
| NL5FEMB80T | In distribution | |
| NL4FEMB40T | In distribution | |
| NL6FEMB40 | In distribution | |
| NL6EMB40T | In distribution | |
| NL7EMB40T | In distribution | |
| NL6FEMB80T | In distribution | |
| NL6FEMB80 | In distribution | |
| NL6FEMB40T | In distribution | |
| NL4FEMB80 | In distribution | |
| NL3FEMB80 | In distribution | |
| 5FEMB40 | In distribution | |
| 6FEMB40 | In distribution | |
| 3FEMB80 | In distribution | |
| NL2EMB60 | In distribution | |
| NL4FEMB100 | In distribution | |
| NL5FEMB40T | In distribution | |
| NL7FEMB80 | In distribution | |
| NL4EMB40T | In distribution | |
| NL2FEMB40 | In distribution | |
| 7FEMB80 | In distribution | |
| NL3EMB40T | In distribution | |
| NL7EMB80 | In distribution | |
| NL2EMB60T | In distribution | |
| NL5EMB40 | In distribution | |
| 3FEMB40 | In distribution | |
| NL4FEMB80T | In distribution | |
| 4FEMB100 | In distribution | |
| NL4EMB80 | In distribution | |
| NL2EMB40 | In distribution | |
| 2FEMB80 | In distribution | |
| NL5FEMB80 | In distribution | |
| NL3EMB80 | In distribution | |
| NL5EMB80 | In distribution | |
| NL3EMB80T | In distribution | |
| NL7EMB40 | In distribution | |
| NL6EMB80T | In distribution | |
| NL4FEMB40 | In distribution | |
| NL3FEMB40T | In distribution | |
| NL4EMB40 | In distribution | |
| 4FEMB80 | In distribution | |
| NL6EMB40 | In distribution | |
| NL2FEMB40T | In distribution | |
| NL4EMB80T | In distribution | |
| 7FEMB40 | In distribution | |
| NL7FEMB40T | In distribution | |
| NL2FEMB60T | In distribution | |
| NL3FEMB80T | In distribution | |
| 4FEMB40 | In distribution | |
| NL7EMB80T | In distribution | |
| NL7FEMB80T | In distribution | |
| 5FEMB80 | In distribution | |
| NL2FEMB60 | In distribution | |
| NL2EMB40T | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| LeMaitre Embolectomy Catheter | Lemaitre Vascular, Inc. | 68 |
| 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 |
| Syntel Silicone OTW Embolectomy Catheter | Lemaitre Vascular, Inc. | 9 |
Showing 12 of 88. All products under Catheter, Embolectomy
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K972623 | 1997-11-19 |
| K970657 | 1997-07-01 |
| K954760 | 1996-04-11 |
| K955125 | 1996-03-11 |
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.