Amplatz Goose Neck
Snare Catheter
1manufacturer
15catalogue 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 | Covidien LP, United States |
|---|---|
| FDA product code | DXE |
| Device type | Catheter, Embolectomy |
| Device class | Class 2 |
| Regulation | 21 CFR 870.5150 |
| 510(k) | K972511 |
| Record published | 2015-10-16 |
| Record revised | 2023-04-13 (version 8) |
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 |
| Storage | Special storage condition: Keep dry |
| Sizes | Length 48 to 200 cm; catheter gauge 4 to 6 Fr; outer diameter 0.038 to 0.052 in; outer diameter 10 to 35 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GN3500 | Outer Diameter 0.052 in | In distribution |
| MC6001 | Length 48 cm | In distribution |
| GN3000 | Outer Diameter 0.052 in | In distribution |
| GN1500 | Outer Diameter 0.052 in | In distribution |
| MC4000 | I.D.,.040,Inch; | In distribution |
| GN2500 | Outer Diameter 0.052 in | In distribution |
| GN500 | Length 120 cm | In distribution |
| MC4001 | Length 48 cm | In distribution |
| GN2000 | Outer Diameter 0.052 in | In distribution |
| GN1001 | Working Length,48,Centimeter;Inner Diameter,.040,Inch; | In distribution |
| MC6000 | Length 102 cm | In distribution |
| SK701 | Length 200 cm | In distribution |
| GN2501 | Working Length,48,Centimeter;Inner Diameter,.063,Inch; | In distribution |
| SK700 | Length 175 cm | In distribution |
| GN1000 | Working Length,102,Centimeter;Inner Diameter,.040,Inch; | 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™ | 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
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 |
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.