510(k) K992368 ยท DXE Catheter, Embolectomy
LEMAITRE EMBOLECTOMY CATHETER
| Applicant | Vascutech, Inc., Burlington MA, US |
| Decision | Substantially Equivalent, Dec 9, 1999 |
| Received | Jul 15, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K992368
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 11, 2022 | LeMaitre Vascular, Inc. TufTex Embolectomy Catheter, Model No.
This catheter has a latex balloon and a single lumen extrusion. It is inserted using a guidewire or introducer. The devices affected by this recall are 3F and Open, Classified |
DXE | None listed |
| Dec 4, 2015 | LeMaitre Vascular, Inc. LeMaitre Single Lumen Embolectomy Catheter 3F, 80 cm, Model 1601-38 and e1601-38. Indicated for the removal of arterial emboli and thrombi. Terminated |
DXE | None listed |
| Dec 4, 2015 | LeMaitre Vascular, Inc. LeMaitre Single Lumen Embolectomy Catheter 4F, 80 cm, Model 1601-48 and e1601-48. Indicated for the removal of arterial emboli and thrombi. Terminated |
DXE | None listed |
| Dec 4, 2015 | LeMaitre Vascular, Inc. LeMaitre Single Lumen Embolectomy Catheter 5F, 80 cm, Model 1601-58 and e1601-58. Indicated for the removal of arterial emboli and thrombi. Terminated |
DXE | None listed |
| Dec 4, 2015 | LeMaitre Vascular, Inc. LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 6F, 80 cm, Model 1601-68. Indicated for the removal of arterial emboli and thrombi. Terminated |
DXE | None listed |
| Dec 4, 2015 | LeMaitre Vascular, Inc. LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 2F, 60 cm, Model e1801-26. Indicated for the removal of arterial emboli and thrombi. Terminated |
DXE | None listed |
| Feb 24, 2005 | Lemaitre Vascular, Inc. LeMaitre Embolectomy Catheter 2F Single Lumen, Balloon Volume 0.05 ml, Length 60 cm. Latex
Model: 1601-26 Terminated |
DXE | None listed |
| Feb 24, 2005 | Lemaitre Vascular, Inc. LeMaitre Embolectomy Catheter 3F Single Lumen, Balloon volume 0.2ml, Length 80 cm, Latex
Model: 1601-38 Terminated |
DXE | None listed |
| Feb 24, 2005 | Lemaitre Vascular, Inc. LeMaitre Embolectomy Catheter 5F Single Lumen, Balloon Volume 1.5 ml, Length 80 cm, Latex
Model: 1601-58 Terminated |
DXE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.