Amplatz Goose Neck™
Accessory MC6000 Angio Catheters V01
1manufacturer
13catalogue numbers in this listing
2recalls 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 | ev3, Inc., United States |
|---|---|
| FDA product code | DXE |
| Device type | Catheter, Embolectomy |
| Device class | Class 2 |
| Regulation | 21 CFR 870.5150 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K972511 |
| Record published | 2020-11-12 |
| Record revised | 2021-07-08 (version 2) |
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 |
| Storage | Special storage condition: Keep away from sunlight; Special storage condition: Store away from sunlight at room temperature in a dry place.; Special storage condition: Keep dry |
| Sizes | Catheter working length 48 to 102 cm; outer diameter 1.33 to 2 mm; catheter inner diameter 1.02 to 1.6 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GN1500 | Wire Diameter 1.32 Millimeter | In distribution |
| MC6000 | Outer Diameter 2.0 mm | In distribution |
| GN3000 | Catheter Working Length 102.0 cm | In distribution |
| GN3500 | Wire Diameter 1.32 Millimeter | In distribution |
| MC4000 | Catheter Working Length 102.0 cm | In distribution |
| MC6001 | Catheter Working Length 48.0 cm | In distribution |
| GN500 | Catheter Working Length 102.0 cm | In distribution |
| GN1000 | Catheter Working Length 102.0 cm | In distribution |
| GN2501 | Outer Diameter 2.0 mm | In distribution |
| GN2000 | Wire Diameter 1.32 Millimeter | In distribution |
| GN2500 | Catheter Working Length 102.0 cm | In distribution |
| MC4001 | Catheter Inner Diameter 1.02 mm | In distribution |
| GN1001 | Snare Length 65 Centimeter | 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 |
| 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
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| ev3, Inc. | 510(k) number | 2007-05-18 | Not classified | Other | Amplatz Goose Neck Snare Kit’s catheter contained in the kit may be 4 Fr instead of the intended 6 Fr. | 23 units | 2008-10-17 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2005-08-16 | Not classified | Other | ev3 has determined that one test unit from each of two lots did not meet mininum tensile strength requirements and therefore the entire lots are being recalled. | 58 | 2006-12-26 |
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.