Arrow
Arrow-Trerotola(TM) Over-The-Wire PTD(R) Kit (Percutaneous Thrombolytic Device)
1manufacturer
28catalogue 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 | Teleflex Medical LLC, United States |
|---|---|
| FDA product code | DXE |
| Device type | Catheter, Embolectomy |
| Device class | Class 2 |
| Regulation | 21 CFR 870.5150 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K011056 |
| Record published | 2016-09-16 |
| Record revised | 2022-03-01 (version 18) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 10 to 25 °C; Special storage condition: Store between 10 – 25°C (50 – 77°F) with relative humidity less than 65%. Avoid excessive cold below -20°C (-4°F) and ex |
| Packaging | Case |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPN035905 | In distribution | |
| IPN036252 | In distribution | |
| IPN920364 | In distribution | |
| IPN035904 | In distribution | |
| IPN035902 | In distribution | |
| IPN920365 | In distribution | |
| IPN036255 | In distribution | |
| IPN035899 | In distribution | |
| IPN035901 | In distribution | |
| IPN920366 | In distribution | |
| IPN920363 | In distribution | |
| IPN035906 | In distribution | |
| IPN036254 | In distribution | |
| IPN036251 | In distribution | |
| IPN920361 | In distribution | |
| IPN914602 | In distribution | |
| IPN920672 | In distribution | |
| IPN920671 | In distribution | |
| IPN914601 | In distribution | |
| IPN035903 | In distribution | |
| IPN036248 | In distribution | |
| IPN036253 | In distribution | |
| IPN920362 | In distribution | |
| IPN036250 | In distribution | |
| IPN920367 | In distribution | |
| IPN035900 | In distribution | |
| IPN036249 | In distribution | |
| IPN035898 | 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 |
| 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
Recalls Naming This Product
13 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Teleflex Medical LLC | UDI-DI | 2022-01-11 | Class I | Process change control | The firm received reports indicating PTD tip separation during use. | 676 units | 2024-09-11 |
| Teleflex Medical LLC | UDI-DI | 2022-01-11 | Class I | Process change control | The firm received reports indicating PTD tip separation during use. | 1400 units | 2024-09-11 |
| Teleflex Medical LLC | UDI-DI | 2022-01-11 | Class I | Process change control | The firm received reports indicating PTD tip separation during use. | 1265 units | 2024-09-11 |
| Teleflex Medical LLC | UDI-DI | 2022-01-11 | Class I | Process change control | The firm received reports indicating PTD tip separation during use. | 1874 units | 2024-09-11 |
| Teleflex Medical LLC | UDI-DI | 2022-01-11 | Class I | Process change control | The firm received reports indicating PTD tip separation during use. | 3668 units | 2024-09-11 |
| Teleflex Medical LLC | UDI-DI | 2022-01-11 | Class I | Process change control | The firm received reports indicating PTD tip separation during use. | 5530 units | 2024-09-11 |
| Teleflex Medical LLC | UDI-DI | 2022-01-11 | Class I | Process change control | The firm received reports indicating PTD tip separation during use. | 14583 units | 2024-09-11 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2021-09-20 | Class I | Unknown/Undetermined by firm | 7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embolization and retrieval with an additional intervention and consequent delay of therapy. | 447 units | 2023-10-05 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2021-09-20 | Class I | Unknown/Undetermined by firm | 7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embolization and retrieval with an additional intervention and consequent delay of therapy. | 1245 units | 2023-10-05 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2021-09-20 | Class I | Unknown/Undetermined by firm | 7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embolization and retrieval with an additional intervention and consequent delay of therapy. | 1167 units | 2023-10-05 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2021-09-20 | Class I | Unknown/Undetermined by firm | 7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embolization and retrieval with an additional intervention and consequent delay of therapy. | 1918 units | 2023-10-05 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2009-02-11 | Not classified | Device Design | Leakage: Material not lipid resistant, may crack and/or leak. Use of this device with lipid containing solutions or 70% isopropyl alcohol may cause leakage or air embolism. | 900,000 total, all products | 2010-07-22 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2005-03-18 | Not classified | Other | The orange Pebax lumen located within the catheter basket may separate from the catheter basket sleeve permitting the lumen to become dislodged during use. | 2418 UNITS | 2006-11-22 |
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.